181 results on '"Bangdiwala, Ananta"'
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2. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial
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Lother, Sylvain A., Abassi, Mahsa, Agostinis, Alyssa, Bangdiwala, Ananta S., Cheng, Matthew P., Drobot, Glen, Engen, Nicole, Hullsiek, Kathy H., Kelly, Lauren E., Lee, Todd C., Lofgren, Sarah M., MacKenzie, Lauren J., Marten, Nicole, McDonald, Emily G., Okafor, Elizabeth C., Pastick, Katelyn A., Pullen, Matthew F., Rajasingham, Radha, Schwartz, Ilan, Skipper, Caleb P., Turgeon, Alexis F., Zarychanski, Ryan, and Boulware, David R.
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- 2020
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3. Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomised, placebo-controlled, double-blind phase 3 trial
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Rhein, Joshua, Huppler Hullsiek, Kathy, Tugume, Lillian, Nuwagira, Edwin, Mpoza, Edward, Evans, Emily E, Kiggundu, Reuben, Pastick, Katelyn A, Ssebambulidde, Kenneth, Akampurira, Andrew, Williams, Darlisha A, Bangdiwala, Ananta S, Abassi, Mahsa, Musubire, Abdu K, Nicol, Melanie R, Muzoora, Conrad, Meya, David B, Boulware, David R, Ndyetukira, Jane Francis, Ahimbisibwe, Cynthia, Kugonza, Florence, Namuju, Carolyne, Sadiq, Alisat, Namudde, Alice, Mwesigye, James, Tadeo, Kiiza K, Kirumira, Paul, Okirwoth, Michael, Luggya, Tonny, Kaboggoza, Julian, Laker, Eva, Atwine, Leo, Muganzi, Davis, Walukaga, Stewart, Jawed, Bilal, Merry, Matthew, Stadelman, Anna, Stephens, Nicole, Flynn, Andrew G, Fujita, Ayako W, Kwizera, Richard, Mukaremera, Liliane, Lofgren, Sarah M, Cresswell, Fiona V, Morawski, Bozena M, Bahr, Nathan C, and Nielsen, Kirsten
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- 2019
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4. Implications of excess weight on kidney donation: Long-term consequences of donor nephrectomy in obese donors
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Serrano, Oscar K., Sengupta, Bodhisatwa, Bangdiwala, Ananta, Vock, David M., Dunn, Ty B., Finger, Erik B., Pruett, Timothy L., Matas, Arthur J., and Kandaswamy, Raja
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- 2018
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5. Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous meningitis in HIV-infected adults: a prospective cohort study
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Williams, Darlisha A, Taseera, Kabanda, Nyehangane, Dan, Ivan, Mugisha, Orikiriza, Patrick, Rhein, Joshua, Hullsiek, Kathy Huppler, Musubire, Abdu, Pastick, Katelyn, Nabeta, Pamela, Mwesigye, James, Rajasingham, Radha, Bahr, Nathan C, Nuwagira, Edwin, Evans, Emily E, Cresswell, Fiona V, Bystrom, Philip V, Byamukama, Adolf, Bridge, Sarah C, Bangdiwala, Ananta S, Meya, David B, Denkinger, Claudia M, Muzoora, Conrad, and Boulware, David R
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- 2018
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6. Estimating Survival in Melanoma Patients With Brain Metastases: An Update of the Graded Prognostic Assessment for Melanoma Using Molecular Markers (Melanoma-molGPA)
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Sperduto, Paul W., Jiang, Wen, Brown, Paul D., Braunstein, Steve, Sneed, Penny, Wattson, Daniel A., Shih, Helen A., Bangdiwala, Ananta, Shanley, Ryan, Lockney, Natalie A., Beal, Kathryn, Lou, Emil, Amatruda, Thomas, Sperduto, William A., Kirkpatrick, John P., Yeh, Norman, Gaspar, Laurie E., Molitoris, Jason K., Masucci, Laura, Roberge, David, Yu, James, Chiang, Veronica, and Mehta, Minesh
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- 2017
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7. Post-Transplant Malignancy after Pediatric Kidney Transplantation: Retrospective Analysis of Incidence and Risk Factors in 884 Patients Receiving Transplants Between 1963 and 2015 at the University of Minnesota
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Serrano, Oscar K., Bangdiwala, Ananta S., Vock, David M., Chinnakotla, Srinath, Dunn, Ty B., Finger, Erik B., Kandaswamy, Raja, Pruett, Timothy L., Najarian, John S., Matas, Arthur J., and Chavers, Blanche M.
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- 2017
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8. The Prognostic Value of BRAF, C-KIT, and NRAS Mutations in Melanoma Patients With Brain Metastases
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Sperduto, Paul W., Jiang, Wen, Brown, Paul D., Braunstein, Steve, Sneed, Penny, Wattson, Daniel A., Shih, Helen A., Bangdiwala, Ananta, Shanley, Ryan, Lockney, Natalie A., Beal, Kathryn, Lou, Emil, Amatruda, Thomas, Sperduto, William A., Kirkpatrick, John P., Yeh, Norman, Gaspar, Laurie E., Molitoris, Jason K., Masucci, Laura, Roberge, David, Yu, James, Chiang, Veronica, and Mehta, Minesh
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- 2017
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9. LEVEL (Logical Explanations & Visualizations of Estimates in Linear mixed models): recommendations for reporting multilevel data and analyses
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Monsalves, Maria Jose, Bangdiwala, Ananta Shrikant, Thabane, Alex, and Bangdiwala, Shrikant Ishver
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- 2020
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10. Vancomycin-resistant Enterococcal Bloodstream Infections in Hematopoietic Stem Cell Transplant Recipients and Patients with Hematologic Malignancies: Impact of Daptomycin MICs of 3 to 4 mg/L
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Chong, Pearlie P., van Duin, David, Bangdiwala, Ananta, Ivanova, Anastasia, Miller, William C., Weber, David J., Gilligan, Peter H., and Shea, Thomas C.
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- 2016
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11. The Effect of Gene Alterations and Tyrosine Kinase Inhibition on Survival and Cause of Death in Patients With Adenocarcinoma of the Lung and Brain Metastases
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Sperduto, Paul W., Yang, T. Jonathan, Beal, Kathryn, Pan, Hubert, Brown, Paul D., Bangdiwala, Ananta, Shanley, Ryan, Yeh, Norman, Gaspar, Laurie E., Braunstein, Steve, Sneed, Penny, Boyle, John, Kirkpatrick, John P., Mak, Kimberley S., Shih, Helen A., Engelman, Alex, Roberge, David, Arvold, Nils D., Alexander, Brian, Awad, Mark M., Contessa, Joseph, Chiang, Veronica, Hardie, John, Ma, Daniel, Lou, Emil, Sperduto, William, and Mehta, Minesh P.
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- 2016
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12. The liver recipient with acute renal dysfunction: A single institution evaluation of the simultaneous liver‐kidney transplant candidate
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Yadav, Kunal, Serrano, Oscar K., Peterson, Kent J., Pruett, Timothy L., Kandaswamy, Raja, Bangdiwala, Ananta, Ibrahim, Hassan, Israni, Ajay, Lake, John, and Chinnakotla, Srinath
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- 2018
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13. Health Care Provider Adherence to Surgical Guidelines for Risk-Reducing Salpingo-Oophorectomy
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Wilhite, Annelise M., Oestreich, Makinna C., Olson, Megan, Bedell, Sabrina M., Westenberg, Danielle, Bangdiwala, Ananta, Ikramuddin, Salman, Sanchez-Avila, Monica, Madoff, Robert D., Khalifa, Mahmoud A., and Erickson, Britt K.
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- 2019
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14. Baseline Cytomegalovirus Viremia at Cryptococcal Meningitis Diagnosis Is Associated With Long-term Increased Incident TB Disease and Mortality in a Prospective Cohort of Ugandan Adults With HIV.
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Ellis, Jayne, Bangdiwala, Ananta S, Skipper, Caleb P, Tugume, Lillian, Nsangi, Laura, Matovu, John, Pastick, Katelyn A, Ssebambulidde, Kenneth, Morawski, Bozena M, Musubire, Abdu K, Schleiss, Mark R, Moore, David A J, Jarvis, Joseph N, Boulware, David R, Meya, David B, and Castelnuovo, Barbara
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BK virus , *TUBERCULOSIS , *MENINGITIS , *VIREMIA , *ENZYME-linked immunosorbent assay , *TYPE I interferons - Abstract
Background Adults with HIV-associated cryptococcal meningitis have overlapping burdens of cytomegalovirus (CMV) and tuberculosis (TB) coinfections. CMV infection/reactivation is strongly associated with CMV-specific memory T-cell activation and upregulation of type 1 interferons, which may lead to increased risk of TB disease and poor outcomes. Methods We conducted a cohort study of 2-week survivors of cryptococcal meningitis during 2010–2021 to determine TB incidence and all-cause mortality over time stratified by baseline CMV status. Results We followed 497 Ugandans with HIV-associated cryptococcal meningitis for a median (interquartile range) of 4.6 (2.6–53.9) months. Overall, 42% (210/497) developed incident TB disease or died. One-fifth (98/497, 19.7%) developed incident TB disease, and 29% (142/497) of participants died during follow-up. Of 259 participants with CMV viral load measured at baseline, 37% (96/259) had concurrent CMV viremia (defined as anyone with detectable CMV DNA in plasma/serum by qualitative polymerase chain reaction [PCR] detection). Of 59 with measured CMV immunoglobulin G (IgG), 100% had positive CMV IgG antibody serology (≥10 enzyme-linked immunosorbent assay units/mL). CMV viremia was positively associated with higher HIV viral load (196 667 vs 73 295 copies/mL; P =.002) and higher cerebrospinal fluid fungal burden (68 500 vs 14 000 cfu/mL; P =.002) compared with those without. Participants with high-level CMV viremia (defined as CMV viral load ≥1000 IU/mL) had twice the risk of incident TB (subdistribution adjusted hazard ratio [aHR], 2.18; 95% CI, 1.11–4.27) and death (aHR, 1.99; 95% CI, 1.14–3.49) compared with participants with no or low-level CMV viremia. There was no association between the CMV IgG index and the incidence of TB/death (P =.75). Conclusions CMV viremia >1000 IU/mL at meningitis diagnosis was associated with increased incident TB disease and mortality during long-term follow-up. Future studies to determine the causal relationship and potential for therapeutic intervention are warranted. [ABSTRACT FROM AUTHOR]
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- 2023
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15. Prophylactic Negative Pressure Wound Therapy in Obese Patients Following Cesarean Delivery
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Looby, Maureen Ayers, Vogel, Rachel Isaksson, Bangdiwala, Ananta, Hyer, Barbara, and Das, Kamalini
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- 2018
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16. Neonatal Morbidity and Maternal Complication Rates in Women With a Delivery Body Mass Index of 60 or Higher
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Kim, Tana, Burn, Sabrina C., Bangdiwala, Ananta, Pace, Samantha, and Rauk, Phillip
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- 2017
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17. Improving Compliance With Preeclampsia Guidelines Through an Electronic Medical Record Alert [29M]
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Scott, Dana M., Rauk, Phillip, and Bangdiwala, Ananta
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- 2017
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18. The Perinatal Birth Environment: Communication Strategies and Processes for Adherence to a Standardized Guideline in Women Undergoing Second-Stage Labor With Epidural Anesthesia
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Sommerness, Samantha A., Gams, Rebecca, Rauk, Phillip N., Bangdiwala, Ananta, Landers, Daniel V., Avery, Melissa D., Hirt, Charles, Miller, Kristi, Millar, Amy, Cho, Suzin, and Shields, Andrea
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- 2017
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19. Outpatient Cryptococcal Antigen Screening Is Associated With Favorable Baseline Characteristics and Improved Survival in Persons With Cryptococcal Meningitis in Uganda.
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Levin, Anna E, Bangdiwala, Ananta S, Nalintya, Elizabeth, Kagimu, Enock, Kasibante, John, Rutakingirwa, Morris K, Mpoza, Edward, Jjunju, Samuel, Nuwagira, Edwin, Naluyima, Rose, Kirumira, Paul, Hou, Cody, Ssebambulidde, Kenneth, Musubire, Abdu K, Williams, Darlisha A, Abassi, Mahsa, Muzoora, Conrad, Hullsiek, Katherine H, Rajasingham, Radha, and Meya, David B
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MENINGITIS diagnosis , *AMPHOTERICIN B , *COMBINATION drug therapy , *CONFIDENCE intervals , *CRYPTOCOCCUS , *MEDICAL screening , *COMPARATIVE studies , *CRYPTOCOCCUS neoformans , *MEDICAL referrals , *DESCRIPTIVE statistics , *RESEARCH funding , *MENINGITIS , *OUTPATIENTS , *ANTIGENS - Abstract
Background It is unknown whether persons with symptomatic cryptococcal meningitis detected during routine blood cryptococcal antigen (CrAg) screening have better survival than persons presenting with overt meningitis. Methods We prospectively enrolled Ugandans with HIV and cryptocococcal meningitis from December 2018 to December 2021. Participants were treated with amphotericin-based combination therapy. We compared outcomes between persons who were CrAg screened then referred to hospital with those presenting directly to the hospital with symptomatic meningitis. Results Among 489 participants with cryptococcal meningitis, 40% (194/489) received blood CrAg screening and were referred to hospital (median time to referral 2 days; interquartile range [IQR], 1–6). CrAg-screened persons referred to hospital had lower 14-day mortality than non–CrAg-screened persons who presented directly to hospital with symptomatic meningitis (12% vs 21%; hazard ratio,.51; 95% confidence interval,.32–.83; P =.006). Fewer CrAg-screened participants had altered mental status versus non–CrAg-screened participants (29% vs 41%; P =.03). CrAg-screened persons had lower quantitative cerebrospinal fluid (CSF) culture burden (median [IQR], 4570 [11–100 000] vs 26 900 [182–324 000] CFU/mL; P =.01) and lower CSF opening pressures (median [IQR], 190 [120–270] vs 225 [140–340] mmH2O; P =.004) compared with non–CrAg-screened persons. Conclusions Survival from cryptococcal meningitis was higher in persons with prior CrAg screening than those without CrAg screening. Altered mental status was the most potent predictor for mortality in a multivariate model. We suggest that CrAg screening detects cryptococcal meningitis at an earlier stage, as evidenced by a favorable baseline risk profile and notably fewer persons with altered mental status. [ABSTRACT FROM AUTHOR]
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- 2023
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20. The effect of sertraline on depression and associations with persistent depression in survivors of HIV-related cryptococcal meningitis
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Lofgren, Sarah M, Velamakanni, Sruti S, Huppler Hullsiek, Katherine, Bangdiwala, Ananta S, Namudde, Alice, Musubire, Abdu K, Mpoza, Edward, Abassi, Mahsa, Pastick, Katelyn A, Nuwagira, Edwin, Evans, Emily E, Rajsasingham, Radha, Williams, Darlisha A, Muzoora, Conrad, Creswell, Fiona V, Rhein, Joshua, Bond, David J, Nakasujja, Noeline, Meya, David B, and Boulware, David R
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Background: Depression is a risk factor for worse outcomes in persons living with HIV/AIDS and has a prevalence more than three times as high as in the general population. Despite this, there are few randomized studies of antidepressants in HIV-infected Africans. Methods: We enrolled 460 HIV-infected Africans with cryptococcal meningitis into a randomized clinical trial of adjunctive sertraline vs placebo (2015-2017). We defined depression using depression using a Center for Epidemiologic Studies Depression Scale (CES-D) score of >15, and severe depression as >26 at one and three months after meningitis diagnosis and initiation of treatment.We evaluated the relationship between sertraline and depression, as well as associations with persistent depression, at three months. Results: At one- and three-months post meningitis diagnosis, 62% (108/174) and 44% (74/169) of all subjects had depression (CES>15), respectively. At three months, sertraline-treated subjects had consistent risk for depression as placebo-treated subjects but were significantly less likely to have severe depression (CES>26) (OR 0.335; 95%CI, 0.130-0.865). Of those with depression at one month, sertraline-treated subjects were less likely than placebo-treated subjects to be depressed at three months (p=0.05). Sertraline was the only factor we found significant in predicting persistent depression at three months among those who had depression at one month. Conclusions: Depression is highly prevalent in HIV-infected persons who have survived cryptococcal meningitis. We found that sertraline is associated with a modest reduction in depression in those with depression at baseline and a significant decrease in severe depression.
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- 2021
21. Fujifilm SILVAMP TB LAM Assay on Cerebrospinal Fluid for the Detection of Tuberculous Meningitis in Adults With Human Immunodeficiency Virus
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Quinn, Carson M, Kagimu, Enock, Okirworth, Michael, Bangdiwala, Ananta S, Mugumya, Gerald, Ramachandran, Prashanth S, Wilson, Michael R, Meya, David B, Cresswell, Fiona V, Bahr, Nathan C, and Boulware, David R
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urologic and male genital diseases - Abstract
BACKGROUND: Tuberculous meningitis (TBM) has a high fatality rate, with inadequate diagnostic tests being a major contributor. The rollout of Xpert MTB/Rif and Xpert MTB/RIF Ultra (Xpert Ultra) have improved time-to-diagnosis with sensitivities similar to culture, yet test availability and sensitivity are inadequate. The TB lipoarabinomannan lateral flow assay (AlereLAM) offers ease of use, but its low sensitivity in cerebrospinal fluid (CSF) limits clinical utility for TBM. The Fujifilm SILVAMP TB LAM (FujiLAM) assay has excellent sensitivity in urine, but performance on cerebrospinal fluid is uncertain. METHODS: We conducted a prospective cohort study at Kiruddu National Referral Hospital in Kampala, Uganda, enrolling patients suspected to have TBM. CSF was tested using AlereLAM, Xpert Ultra, culture, and FujiLAM. Results were compared with 2 reference standards: probable and definite TBM or definite TBM alone by the uniform TBM case definition. RESULTS: Of 101 patients enrolled (95/101 HIV-positive), 34 had definite TBM and 24 had probable TBM. FujiLAM sensitivity on CSF was 52% (30/58) for definite or probable TBM compared with 55% (32/58) for Xpert Ultra. AlereLAM had lower sensitivity than FujiLAM in the subgroup of patients tested with both assays (14% [4/28] vs 50% [14/28]; P < .01). FujiLAM specificity was 98% (42/43) for patients without probable or definite TBM. CONCLUSIONS: FujiLAM showed higher sensitivity than AlereLAM, with sensitivity potentially approaching that of Xpert Ultra. FujiLAM could improve time-to-treatment-initiation, especially in settings where the more technical Xpert Ultra system might not be feasible. Large confirmatory studies are needed.
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- 2021
22. Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial
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Rajasingham, Radha, Bangdiwala, Ananta S, Nicol, Melanie R, Skipper, Caleb P, Pastick, Katelyn A, Axelrod, Margaret L, Pullen, Matthew F, Nascene, Alanna A, Williams, Darlisha A, Engen, Nicole W, Okafor, Elizabeth C, Rini, Brian I, Mayer, Ingrid A, McDonald, Emily G, Lee, Todd C, Li, Peter, MacKenzie, Lauren J, Balko, Justin M, Dunlop, Stephen J, Hullsiek, Katherine H, Boulware, David R, Lofgren, Sarah M, Abassi, Mahsa, Balster, Andrew, Collins, Lindsey B, Drobot, Glen, Krakower, Douglas S, Lother, Sylvain A, MacKay, Dylan S, Meyer-Mueller, Cameron, Selinsky, Stephen, Solvason, Dayna, Zarychanski, Ryan, and Zash, Rebecca
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0301 basic medicine ,Microbiology (medical) ,Canada ,medicine.medical_specialty ,Health Personnel ,Placebo ,Loading dose ,law.invention ,03 medical and health sciences ,Pre-exposure prophylaxis ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Intensive care ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Online Only Articles ,SARS-CoV-2 ,business.industry ,Hydroxychloroquine ,COVID-19 Drug Treatment ,Clinical trial ,030104 developmental biology ,Infectious Diseases ,Pre-Exposure Prophylaxis ,business ,medicine.drug - Abstract
Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing coronavirus disease 2019 (COVID-19) pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure. Methods We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, COVID-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine loading dose then 400 mg once or twice weekly for 12 weeks. The primary endpoint was confirmed or probable COVID-19–compatible illness. We measured hydroxychloroquine whole-blood concentrations. Results We enrolled 1483 healthcare workers, of whom 79% reported performing aerosol-generating procedures. The incidence of COVID-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events/person-year with once-weekly and 0.28 events/person-year with twice-weekly hydroxychloroquine compared with 0.38 events/person-year with placebo. For once-weekly hydroxychloroquine prophylaxis, the hazard ratio was .72 (95% CI, .44–1.16; P = .18) and for twice-weekly was .74 (95% CI, .46–1.19; P = .22) compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82–120) with once-weekly and 200 ng/mL (IQR, 159–258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed COVID-19–compatible illness (154 ng/mL) versus participants without COVID-19 (133 ng/mL; P = .08). Conclusions Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed COVID-19 or COVID-19–compatible illness among healthcare workers. Clinical Trials Registration Clinicaltrials.gov NCT04328467.
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- 2020
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23. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19
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Skipper, Caleb P., Pastick, Katelyn A., Engen, Nicole W., Bangdiwala, Ananta S., Abassi, Mahsa, Lofgren, Sarah M., Williams, Darlisha A., Okafor, Elizabeth C., Pullen, Matthew F., Nicol, Melanie R., Nascene, Alanna A., Hullsiek, Kathy H., Cheng, Matthew P., Luke, Darlette, Lother, Sylvain A., MacKenzie, Lauren J., Drobot, Glen, Kelly, Lauren E., Schwartz, Ilan S., Zarychanski, Ryan, McDonald, Emily G., Lee, Todd C., Rajasingham, Radha, and Boulware, David R.
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stomatognathic diseases ,Original Research - Abstract
There is no known effective oral therapy for early COVID-19. This randomized, double-blind, placebo-controlled trial evaluated effects of oral hydroxychloroquine on symptoms and disease severity in adult outpatients with early COVID-19., Background: No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). Objective: To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. Design: Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668) Setting: Internet-based trial across the United States and Canada (40 states and 3 provinces). Participants: Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. Intervention: Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. Measures: Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days. Results: Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, −0.27 points [95% CI, −0.61 to 0.07 points]; P = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo (P = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (P < 0.001). With placebo, 10 hospitalizations occurred (2 non–COVID-19–related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (P = 0.29). Limitations: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages. Conclusion: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. Primary Funding Source: Private donors., Visual Abstract. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 There is no known effective oral therapy for early COVID-19. This randomized, double-blind, placebo-controlled trial evaluated effects of oral hydroxychloroquine on symptoms and disease severity in adult outpatients with early COVID-19. Visual Abstract. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 There is no known effective oral therapy for early COVID-19. This randomized, double-blind, placebo-controlled trial evaluated effects of oral hydroxychloroquine on symptoms and disease severity in adult outpatients with early COVID-19.
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- 2020
24. Cerebrospinal Fluid Lactate as a Prognostic Marker of Disease Severity and Mortality in Cryptococcal Meningitis.
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Abassi, Mahsa, Bangdiwala, Ananta S, Nuwagira, Edwin, Tadeo, Kiiza Kandole, Okirwoth, Michael, Williams, Darlisha A, Mpoza, Edward, Tugume, Lillian, Ssebambulidde, Kenneth, Hullsiek, Kathy Huppler, Musubire, Abdu K, Muzoora, Conrad, Rhein, Joshua, Meya, David B, and Boulware, David R
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CEREBROSPINAL fluid examination , *HIV-positive persons , *BIOMARKERS , *CONFIDENCE intervals , *POINT-of-care testing , *MULTIVARIATE analysis , *SEVERITY of illness index , *LACTATES , *CRYPTOCOCCUS neoformans , *DESCRIPTIVE statistics , *MENINGITIS , *EVALUATION - Abstract
Background Cerebrospinal fluid (CSF) lactate levels can be used to differentiate between bacterial and viral meningitis. We measured CSF lactate in individuals with cryptococcal meningitis to determine its clinical significance. Methods We measured point-of-care CSF lactate at the bedside of 319 Ugandan adults living with human immunodeficiency virus at diagnosis of cryptococcal meningitis. We summarized demographic variables and clinical characteristics by CSF lactate tertiles. We evaluated the association of CSF lactate with clinical characteristics and survival. Results Individuals with high CSF lactate >5 mmol/L at cryptococcal diagnosis more likely presented with altered mental status (P < .0001), seizures (P = .0005), elevated intracranial opening pressure (P = .03), higher CSF white cells (P = .007), and lower CSF glucose (P = .0003) compared with those with mid-range (3.1 to 5 mmol/L) or low (≤3 mmol/L) CSF lactate levels. Two-week mortality was higher among individuals with high baseline CSF lactate >5 mmol/L (35%; 38 of 109) compared with individuals with mid-range (22%; 25 of 112) or low CSF lactate (9%; 9 of 97; P =<.0001). After multivariate adjustment, CSF lactate >5 mmol/L remained independently associated with excess mortality (adjusted hazard ratio = 3.41; 95% confidence interval, 1.55–7.51; P = .002). We found no correlation between baseline CSF lactate levels and blood capillary lactate levels. Conclusions Baseline point-of-care CSF lactate levels are a prognostic marker of disease severity and mortality in cryptococcal meningitis. Individuals with an elevated baseline CSF lactate level are more likely to present with altered mental status, seizures, and elevated CSF opening pressure and are at a greater risk of death. Future studies are needed to determine targeted therapeutic management strategies in persons with high CSF lactate. [ABSTRACT FROM AUTHOR]
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- 2021
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25. Cerebrospinal Fluid Bacillary Load by Xpert MTB/RIF Ultra Polymerase Chain Reaction Cycle Threshold Value Predicts 2-Week Mortality in Human Immunodeficiency Virus–Associated Tuberculous Meningitis.
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Martyn, Emily M, Bangdiwala, Ananta S, Kagimu, Enock, Rutakingirwa, Morris K, Kasibante, John, Okirwoth, Michael, Stead, Gavin, Wadda, Vincent, Pullen, Matthew F, Bold, Tyler D, Meya, David B, Boulware, David R, Bahr, Nathan C, and Cresswell, Fiona V
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HIV infection complications , *MYCOBACTERIUM , *PREDICTIVE tests , *MOLECULAR diagnosis , *VIRAL load , *LACTATES , *CEREBROSPINAL fluid , *POLYMERASE chain reaction , *LONGITUDINAL method - Abstract
Background The World Health Organization recommends GeneXpert MTB/RIF Ultra (Xpert Ultra), a fully automated polymerase chain reaction (PCR) assay, as the initial tuberculous meningitis (TBM) diagnostic test. The assay's PCR cycle threshold (Ct) values represent the number of PCR cycles required for probe signal to be detected (low Ct value = high bacillary load) and may approximate tuberculosis (TB) bacillary load. We measured the relationship between cerebrospinal fluid (CSF) TB bacillary load with mortality. Methods We prospectively enrolled 102 human immunodeficiency virus (HIV)–positive Ugandans with probable or definite TBM from April 2015 to August 2019. Xpert Ultra Ct tertiles and semi-quantitative categories were separately analyzed as predictors of 2-week mortality. We investigated associations between Ct and baseline clinical and CSF parameters. Results Subjects with Ct values in the low tertile (ie, high bacillary load) had 57% 2-week mortality—worse than the intermediate (17%) and high (25%) Ct tertiles and Xpert Ultra–negative (30%) probable TBM cases (P = .01). In contrast, the reported semi-quantitative Xpert Ultra categorization was less precise; with the medium to low category trending toward worse 2-week survival (42%) compared with very low (28%), trace (26%), and negative (30%) categories (P = .48). Ct tertile was significantly associated with baseline CSF lactate (P = .03). Conclusions High CSF TB bacillary load, as measured by Xpert Ultra Ct tertile, is associated with an almost 2-fold higher 2-week mortality in HIV-associated TBM and is a better predictor than the reported Xpert Ultra semi-quantitative category. Xpert Ultra Ct values could identify TBM patients at increased risk of death who may benefit from enhanced supportive care. [ABSTRACT FROM AUTHOR]
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- 2021
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26. Feasibility of SARS-CoV-2 Antibody Testing in Remote Outpatient Trials.
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Lofgren, Sarah M, Okafor, Elizabeth C, Colette, Alanna A, Pastick, Katelyn A, Skipper, Caleb P, Pullen, Matthew F, Nicol, Melanie R, Bold, Tyler D, Bangdiwala, Ananta S, Engen, Nicole W, Collins, Lindsey B, Williams, Darlisha A, Axelrod, Margaret L, Thielen, Beth K, Hullsiek, Kathy H, Boulware, David R, and Rajasingham, Radha
- Subjects
ANTIBODY titer ,COVID-19 ,COVID-19 testing ,OUTPATIENTS ,ENZYME-linked immunosorbent assay - Abstract
Background During the coronavirus disease 2019 (COVID-19) pandemic, clinical trials necessitated rapid testing to be performed remotely. Dried blood spot (DBS) techniques have enabled remote HIV virologic testing globally, and more recently, antibody testing as well. We evaluated DBS testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody testing in outpatients to assess seropositivity. Methods In 2020, we conducted 3 internet-based randomized clinical trials and offered serologic testing via self-collected DBS as a voluntary substudy. COVID-19 diagnosis was based on the Centers for Disease Control and Prevention case definition with epidemiological link to cases. A minority reported polymerase chain reaction (PCR) testing at an outside facility. We tested for anti-SARS-CoV-2 immunoglobulin via antibody detection by agglutination–PCR (ADAP) and compared the results with enzyme-linked immunosorbent assay (ELISA). Results Of 2727 participants in the primary studies, 60% (1648/2727) consented for serology testing; 56% (931/1648) returned a usable DBS sample. Of those who were asymptomatic, 5% (33/707) had positive ADAP serology. Of participants with a positive PCR, 67% (36/54) had positive SARS-CoV-2 antibodies. None of those who were PCR-positive and asymptomatic were seropositive (0/7). Of 77 specimens tested for concordance via ELISA, 83% (64/77) were concordant. The challenges of completing a remote testing program during a pandemic included sourcing and assembling collection kits, delivery and return of the kits, and troubleshooting testing. Self-collection was successful for >95% of participants. Delays in US mail with possible sample degradation and timing of DBS collection complicated the analysis. Conclusions We found remote antibody testing during a global pandemic feasible although challenging. We identified an association between symptomatic COVID-19 and positive antibody results at a similar prevalence as other outpatient cohorts. [ABSTRACT FROM AUTHOR]
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- 2021
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27. The Changing Epidemiology of HIV-Associated Adult Meningitis, Uganda 2015–2017
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Ellis, Jayne, Bangdiwala, Ananta S, Cresswell, Fiona V, Rhein, Joshua, Nuwagira, Edwin, Ssebambulidde, Kenneth, Tugume, Lillian, Rajasingham, Radha, Bridge, Sarah C, Muzoora, Conrad, Meya, David B, Boulware, David R, and ASTRO-CM Team
- Abstract
BACKGROUND: Central nervous system (CNS) infections remain a major public health problem in Sub-Saharan Africa, causing 15%-25% of AIDS-related deaths. With widespread availability of antiretroviral therapy (ART) and the introduction of improved diagnostics, the epidemiology of infectious meningitis is evolving. METHODS: We prospectively enrolled adults presenting with HIV-associated meningitis in Kampala and Mbarara, Uganda, from March 2015 to September 2017. Participants had a structured, stepwise diagnostic algorithm performed of blood cryptococcal antigen (CrAg), CSF CrAg, Xpert MTB/RIF for tuberculous (TB) meningitis (TBM), Biofire multiplex polymerase chain reaction, and traditional microscopy and cultures. RESULTS: We screened 842 consecutive adults with HIV presenting with suspected meningitis: 57% men, median age 35 years, median CD4 26 cells/mcL, and 55% presented on ART. Overall, 60.5% (509/842) were diagnosed with first-episode cryptococcal meningitis and 7.4% (62/842) with second episode. Definite/probable TB meningitis was the primary diagnosis in 6.9% (58/842); 5.3% (n = 45) had microbiologically confirmed (definite) TB meningitis. An additional 7.8% (66/842) did not meet the diagnostic threshold for definite/probable TBM but received empiric TBM therapy. Bacterial and viral meningitis were diagnosed in 1.3% (11/842) and 0.7% (6/842), respectively. The adoption of a cost-effective stepwise diagnostic algorithm allowed 79% (661/842) to have a confirmed microbiological diagnosis at an average cost of $44 per person. CONCLUSIONS: Despite widespread ART availability, Cryptococcus remains the leading cause of HIV-associated meningitis. The second most common etiology was TB meningitis, treated in 14.7% overall. The increased proportion of microbiologically confirmed TBM cases reflects the impact of new improved molecular diagnostics.
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- 2019
28. High-Dose Oral and Intravenous Rifampicin for the Treatment of Tuberculous Meningitis in Predominantly Human Immunodeficiency Virus (HIV)-Positive Ugandan Adults: A Phase II Open-Label Randomized Controlled Trial.
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Cresswell, Fiona V, Meya, David B, Kagimu, Enock, Grint, Daniel, Brake, Lindsey te, Kasibante, John, Martyn, Emily, Rutakingirwa, Morris, Quinn, Carson M, Okirwoth, Micheal, Tugume, Lillian, Ssembambulidde, Kenneth, Musubire, Abdu K, Bangdiwala, Ananta S, Buzibye, Allan, Muzoora, Conrad, Svensson, Elin M, Aarnoutse, Rob, Boulware, David R, and Elliott, Alison M
- Subjects
HIV-positive persons ,INTRAVENOUS therapy ,CONFIDENCE intervals ,ORAL drug administration ,CD4 antigen ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,DESCRIPTIVE statistics ,RIFAMPIN ,CEREBROSPINAL fluid - Abstract
Background High-dose rifampicin may improve outcomes of tuberculous meningitis (TBM). Little safety or pharmacokinetic (PK) data exist on high-dose rifampicin in human immunodeficiency virus (HIV) coinfection, and no cerebrospinal fluid (CSF) PK data exist from Africa. We hypothesized that high-dose rifampicin would increase serum and CSF concentrations without excess toxicity. Methods In this phase II open-label trial, Ugandan adults with suspected TBM were randomized to standard-of-care control (PO-10, rifampicin 10 mg/kg/day), intravenous rifampicin (IV-20, 20 mg/kg/day), or high-dose oral rifampicin (PO-35, 35 mg/kg/day). We performed PK sampling on days 2 and 14. The primary outcomes were total exposure (AUC
0–24 ), maximum concentration (Cmax ), CSF concentration, and grade 3–5 adverse events. Results We enrolled 61 adults, 92% were living with HIV, median CD4 count was 50 cells/µL (interquartile range [IQR] 46–56). On day 2, geometric mean plasma AUC0–24hr was 42.9·h mg/L with standard-of-care 10 mg/kg dosing, 249·h mg/L for IV-20 and 327·h mg/L for PO-35 (P < .001). In CSF, standard of care achieved undetectable rifampicin concentration in 56% of participants and geometric mean AUC0–24hr 0.27 mg/L, compared with 1.74 mg/L (95% confidence interval [CI] 1.2–2.5) for IV-20 and 2.17 mg/L (1.6–2.9) for PO-35 regimens (P < .001). Achieving CSF concentrations above rifampicin minimal inhibitory concentration (MIC) occurred in 11% (2/18) of standard-of-care, 93% (14/15) of IV-20, and 95% (18/19) of PO-35 participants. Higher serum and CSF levels were sustained at day 14. Adverse events did not differ by dose (P = .34). Conclusions Current international guidelines result in sub-therapeutic CSF rifampicin concentration for 89% of Ugandan TBM patients. High-dose intravenous and oral rifampicin were safe and respectively resulted in exposures ~6- and ~8-fold higher than standard of care, and CSF levels above the MIC. [ABSTRACT FROM AUTHOR]- Published
- 2021
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29. Short Communication: A Descriptive Analysis of Dried Blood Spot Adherence Testing Among Ugandans with HIV Presenting with Cryptococcal Meningitis.
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Lofgren, Sarah M., Nicol, Melanie R., Kandole, Tadeo K., Castillo-Mancilla, Jose, Anderson, Peter L., Mpoza, Edward, Tugume, Lillian, Bangdiwala, Ananta S., Ssebambulidde, Kenneth, Hullsiek, Katherine Huppler, Rhein, Joshua, Meya, David B., and Boulware, David R.
- Abstract
Early antiretroviral therapy (ART) initiation after cryptococcal meningitis increases mortality, and those unmasking cryptococcosis after <2 weeks of ART have higher mortality. However, it is unknown if those presenting as ART experienced are actually adherent to their ART. Unknowingly, restarting ART in persons, who have discontinued ART, may be a fatal iatrogenic error. To evaluate ART adherence in an exploratory analysis, we collected dried blood spots on 44 HIV-infected persons presenting with cryptococcal meningitis. We quantified tenofovir diphosphate (TFV-DP) and lamivudine (3TC) from dried blood spots. We quantified cumulative ART adherence over the preceding 6–8 weeks based on TFV-DP concentrations and adherence over the last few days based on 3TC concentrations. Of 22 ART experienced, 20 (91%) had quantifiable concentrations. Of 18 receiving tenofovir, 15 (83%) had TFV-DP consistent with drug intake of ≥4 doses/week or moderate adherence. With 3TC, 72% (18/22) had detectable levels consistent with adherence over the last 3 days before measurement. Only three ART-experienced subjects were alive and virally suppressed at 4 months (n = 2 on ART for <30 days; n = 1 with undetectable antiretrovirals). Surprisingly, of 22 who reported not receiving ART, 4 (18%) had quantifiable tenofovir. Most ART-experienced subjects were taking their ART with moderate to good adherence with the majority likely having viral resistance given generally at good ART levels, receipt of intensive adherence counseling, and lack of subsequent viral suppression. The World Health Organization (WHO) guidelines recommend adherence counseling with ART continuation and repeat viral loads in 1–3 months before switching to second-line ART. These recommendations are likely inappropriate in those with central nervous system infections given the additional possible harm of central nervous system immune reconstitution syndrome. Further study to evaluate continuation of ART regimens when presenting with cryptococcosis has benefit, with checking blood levels at presentation potentially being a helpful option. ClinicalTrials.gov Identifier: NCT01802385. [ABSTRACT FROM AUTHOR]
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- 2021
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30. Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial.
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Rajasingham, Radha, Bangdiwala, Ananta S, Nicol, Melanie R, Skipper, Caleb P, Pastick, Katelyn A, Axelrod, Margaret L, Pullen, Matthew F, Nascene, Alanna A, Williams, Darlisha A, Engen, Nicole W, Okafor, Elizabeth C, Rini, Brian I, Mayer, Ingrid A, McDonald, Emily G, Lee, Todd C, Li, Peter, MacKenzie, Lauren J, Balko, Justin M, Dunlop, Stephen J, and Hullsiek, Katherine H
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INTENSIVE care units , *COVID-19 , *HOSPITAL emergency services , *CONFIDENCE intervals , *TREATMENT effectiveness , *RANDOMIZED controlled trials , *BLIND experiment , *HYDROXYCHLOROQUINE , *PREVENTIVE medicine - Abstract
Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing coronavirus disease 2019 (COVID-19) pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure. Methods We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, COVID-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine loading dose then 400 mg once or twice weekly for 12 weeks. The primary endpoint was confirmed or probable COVID-19–compatible illness. We measured hydroxychloroquine whole-blood concentrations. Results We enrolled 1483 healthcare workers, of whom 79% reported performing aerosol-generating procedures. The incidence of COVID-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events/person-year with once-weekly and 0.28 events/person-year with twice-weekly hydroxychloroquine compared with 0.38 events/person-year with placebo. For once-weekly hydroxychloroquine prophylaxis, the hazard ratio was.72 (95% CI,.44–1.16; P =.18) and for twice-weekly was.74 (95% CI,.46–1.19; P =.22) compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82–120) with once-weekly and 200 ng/mL (IQR, 159–258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed COVID-19–compatible illness (154 ng/mL) versus participants without COVID-19 (133 ng/mL; P =.08). Conclusions Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed COVID-19 or COVID-19–compatible illness among healthcare workers. Clinical Trials Registration Clinicaltrials.gov NCT04328467. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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31. Symptomatic Cryptococcal Antigenemia Presenting as Early Cryptococcal Meningitis With Negative Cerebral Spinal Fluid Analysis
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Ssebambulidde, Kenneth, Bangdiwala, Ananta S, Kwizera, Richard, Kandole, Tadeo Kiiza, Tugume, Lillian, Kiggundu, Reuben, Mpoza, Edward, Nuwagira, Edwin, Williams, Darlisha A, Lofgren, Sarah M, Abassi, Mahsa, Musubire, Abdu K, Cresswell, Fiona V, Rhein, Joshua, Muzoora, Conrad, Hullsiek, Kathy Huppler, Boulware, David R, Meya, David B, and Adjunctive Sertraline for Treatment of HIV-associated Cryptococc
- Abstract
BACKGROUND: Individuals with cryptococcal antigenemia are at high risk of developing cryptococcal meningitis if untreated. The progression and timing from asymptomatic infection to cryptococcal meningitis is unclear. We describe a subpopulation of individuals with neurologic symptomatic cryptococcal antigenemia but negative cerebral spinal fluid (CSF) studies. METHODS: We evaluated 1201 human immunodeficiency virus-seropositive individuals hospitalized with suspected meningitis in Kampala and Mbarara, Uganda. Baseline characteristics and clinical outcomes of participants with neurologic-symptomatic cryptococcal antigenemia and negative CSF cryptococcal antigen (CrAg) were compared to participants with confirmed CSF CrAg+ cryptococcal meningitis. Additional CSF testing included microscopy, fungal culture, bacterial culture, tuberculosis culture, multiplex FilmArray polymerase chain reaction (PCR; Biofire), and Xpert MTB/Rif. RESULTS: We found 56% (671/1201) of participants had confirmed CSF CrAg+ cryptococcal meningitis and 4% (54/1201) had neurologic symptomatic cryptococcal antigenemia with negative CSF CrAg. Of those with negative CSF CrAg, 9% (5/54) had Cryptococcus isolated on CSF culture (n = 3) or PCR (n = 2) and 11% (6/54) had confirmed tuberculous meningitis. CSF CrAg-negative patients had lower proportions with CSF pleocytosis (16% vs 26% with ≥5 white cells/μL) and CSF opening pressure >200 mmH2O (16% vs 71%) compared with CSF CrAg-positive patients. No cases of bacterial or viral meningitis were detected by CSF PCR or culture. In-hospital mortality was similar between symptomatic cryptococcal antigenemia (32%) and cryptococcal meningitis (31%; P = .91). CONCLUSIONS: Cryptococcal antigenemia with meningitis symptoms was the third most common meningitis etiology. We postulate this is early cryptococcal meningoencephalitis. Fluconazole monotherapy was suboptimal despite Cryptococcus-negative CSF. Further studies are warranted to understand the clinical course and optimal management of this distinct entity. CLINICAL TRIALS REGISTRATION: NCT01802385.
- Published
- 2018
32. Lessons Learned From Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic.
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Pullen, Matthew F, Pastick, Katelyn A, Williams, Darlisha A, Nascene, Alanna A, Bangdiwala, Ananta S, Okafor, Elizabeth C, Hullsiek, Katherine Huppler, Skipper, Caleb P, Lofgren, Sarah M, Engen, Nicole, Abassi, Mahsa, McDonald, Emily G, Lee, Todd C, Rajasingham, Radha, and Boulware, David R
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CLINICAL trials ,COVID-19 pandemic ,PANDEMICS ,EXPERIMENTAL design ,DISEASE prevalence ,HEALTH care reminder systems - Abstract
As the severe acute respiratory syndrome coronavirus 2 pandemic evolved, it was apparent that well designed and rapidly conducted randomized clinical trials were urgently needed. However, traditional clinical trial design presented several challenges. Notably, disease prevalence initially varied by time and region, and the pockets of outbreaks evolved geographically over time. Coupled with an occupational hazard from in-person study visits, timely recruitment would prove difficult in a traditional in-person clinical trial. Thus, our team opted to launch nationwide internet-based clinical trials using patient-reported outcome measures. In total, 2795 participants were recruited using traditional and social media, with screening and enrollment performed via an online data capture system. Follow-up surveys and survey reminders were similarly managed through this online system with manual participant outreach in the event of missing data. In this report, we present a narrative of our experience running internet-based clinical trials and provide recommendations for the design of future clinical trials during a world pandemic. [ABSTRACT FROM AUTHOR]
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- 2021
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33. Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial.
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Boulware, David R, Nalintya, Elizabeth, Rajasingham, Radha, Kirumira, Paul, Naluyima, Rose, Turya, Fred, Namanda, Sylvia, Rutakingirwa, Morris K, Skipper, Caleb P, Nikweri, Yofesi, Hullsiek, Kathy Huppler, Bangdiwala, Ananta S, and Meya, David B
- Abstract
Cryptococcal antigen (CrAg) screening in HIV-infected persons with CD4 < 100 cells/µl can reduce meningitis and death, yet preemptive fluconazole therapy fails in ∼25%. Sertraline has in vitro and in vivo activity against Cryptococcus and is synergistic with fluconazole in mice. We evaluated the efficacy and safety of sertraline in asymptomatic cryptococcal antigenemia. We conducted a randomized trial of asymptomatic CrAg-positive Ugandans from November 2017 to February 2018. All subjects received WHO standard therapy of fluconazole 800 mg for 2 weeks, then 400 mg for 10 weeks, then 200 mg through 24 weeks. Participants were randomized to receive adjunctive sertraline or placebo, given in once-weekly escalating 100 mg/day doses up to 400 mg/day, which was then given for 8 weeks, then tapered. The primary endpoint was meningitis-free 6-month survival. The data and safety monitoring board halted the trial after 21 subjects were enrolled due to safety concerns. Meningitis-free 6-month survival occurred in 9 of 11 of placebo participants and 10 of 10 of sertraline participants. However, seven serious adverse events (SAEs) occurred (n = 4 sertraline group; n = 3 placebo group). Three SAEs in the sertraline group presented with psychosis and aggressive behavioral changes with one meeting Hunter's criteria for serotonin syndrome while receiving 200 mg/day sertraline. Two transient psychoses were associated with antecedent fluconazole and sertraline interruption. The serotonin syndrome resolved within 1 day, but psychosis persisted for 4 months after sertraline discontinuation. Sertraline was associated with excess SAEs of psychosis. Due to early stopping, we were unable to determine any efficacy for cryptococcal antigenemia. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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34. Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
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Lofgren, Sarah M, Nicol, Melanie R, Bangdiwala, Ananta S, Pastick, Katelyn A, Okafor, Elizabeth C, Skipper, Caleb P, Pullen, Matthew F, Engen, Nicole W, Abassi, Mahsa, Williams, Darlisha A, Nascene, Alanna A, Axelrod, Margaret L, Lother, Sylvain A, MacKenzie, Lauren J, Drobot, Glen, Marten, Nicole, Cheng, Matthew P, Zarychanski, Ryan, Schwartz, Ilan S, and Silverman, Michael
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DRUG side effects ,COVID-19 ,HYDROXYCHLOROQUINE ,COVID-19 treatment ,ATRIAL arrhythmias ,CLINICAL trials - Abstract
Background Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials. Methods We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings. Results We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34–49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred. Conclusions Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19. ClinicalTrials.gov Identifier NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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35. Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous meningitis in HIV-infected adults: a prospective cohort study
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Bahr, Nathan C, Nuwagira, Edwin, Evans, Emily E, Cresswell, Fiona V, Bystrom, Philip V, Byamukama, Adolf, Bridge, Sarah C, Bangdiwala, Ananta S, Meya, David B, Denkinger, Claudia M, Muzoora, Conrad, Boulware, David R, and ASTRO-CM Trial Team
- Abstract
BACKGROUND: WHO recommends Xpert MTB/RIF as initial diagnostic testing for tuberculous meningitis. However, diagnosis remains difficult, with Xpert sensitivity of about 50-70% and culture sensitivity of about 60%. We evaluated the diagnostic performance of the new Xpert MTB/RIF Ultra (Xpert Ultra) for tuberculous meningitis. METHODS: We prospectively obtained diagnostic cerebrospinal fluid (CSF) specimens during screening for a trial on the treatment of HIV-associated cryptococcal meningitis in Mbarara, Uganda. HIV-infected adults with suspected meningitis (eg, headache, nuchal rigidity, altered mental status) were screened consecutively at Mbarara Regional Referral Hospital. We centrifuged CSF, resuspended the pellet in 2 mL of CSF, and tested 0·5 mL with mycobacteria growth indicator tube culture, 1 mL with Xpert, and cryopreserved 0·5 mL, later tested with Xpert Ultra. We assessed diagnostic performance against uniform clinical case definition or a composite reference standard of any positive CSF tuberculous test. FINDINGS: From Feb 27, 2015, to Nov 7, 2016, we prospectively evaluated 129 HIV-infected adults with suspected meningitis for tuberculosis. 23 participants were classified as probable or definite tuberculous meningitis by uniform case definition, excluding Xpert Ultra results. Xpert Ultra sensitivity was 70% (95% CI 47-87; 16 of 23 cases) for probable or definite tuberculous meningitis compared with 43% (23-66; 10/23) for Xpert and 43% (23-66; 10/23) for culture. With composite standard, we detected tuberculous meningitis in 22 (17%) of 129 participants. Xpert Ultra had 95% sensitivity (95% CI 77-99; 21 of 22 cases) for tuberculous meningitis, which was higher than either Xpert (45% [24-68]; 10/22; p=0·0010) or culture (45% [24-68]; 10/22; p=0·0034). Of 21 participants positive by Xpert Ultra, 13 were positive by culture, Xpert, or both, and eight were only positive by Xpert Ultra. Of those eight, three were categorised as probable tuberculous meningitis, three as possible tuberculous meningitis, and two as not tuberculous meningitis. Testing 6 mL or more of CSF was associated with more frequent detection of tuberculosis than with less than 6 mL (26% vs 7%; p=0·014). INTERPRETATION: Xpert Ultra detected significantly more tuberculous meningitis than did either Xpert or culture. WHO now recommends the use of Xpert Ultra as the initial diagnostic test for suspected tuberculous meningitis. FUNDING: National Institute of Neurologic Diseases and Stroke, Fogarty International Center, National Institute of Allergy and Infectious Disease, UK Medical Research Council/DfID/Wellcome Trust Global Health Trials, Doris Duke Charitable Foundation.
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- 2017
36. Evaluation of a reduced nicotine product standard: Moderating effects of and impact on cannabis use
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Pacek, Lauren R., Vandrey, Ryan, Dermody, Sarah S., Denlinger-Apte, Rachel L., Lemieux, Andrine, Tidey, Jennifer W., McClernon, F. Joseph, Bangdiwala, Ananta S., Drobes, David J., al’Absi, Mustafa, Strasser, Andrew A., Koopmeiners, Joseph S., Hatsukami, Dorothy K., and Donny, Eric C.
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- 2016
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37. Cerebrospinal Fluid Early Fungicidal Activity as a Surrogate Endpoint for Cryptococcal Meningitis Survival in Clinical Trials.
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Pullen, Matthew F, Hullsiek, Katherine Huppler, Rhein, Joshua, Musubire, Abdu K, Tugume, Lillian, Nuwagira, Edwin, Abassi, Mahsa, Ssebambulidde, Kenneth, Mpoza, Edward, Kiggundu, Ruben, Akampurira, Andrew, Nabeta, Henry W, Schutz, Charlotte, Evans, Emily E, Rajasingham, Radha, Skipper, Caleb P, Pastick, Katelyn A, Williams, Darlisha A, Morawski, Bozena M, and Bangdiwala, Ananta S
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CEREBROSPINAL fluid examination ,AMPHOTERICIN B ,ANTIFUNGAL agents ,CLINICAL trials ,CRYPTOCOCCUS neoformans ,CULTURES (Biology) ,FUNGI ,MENINGITIS ,REGRESSION analysis ,SURVIVAL ,SECONDARY analysis ,PROPORTIONAL hazards models ,DESCRIPTIVE statistics ,FLUCONAZOLE ,COLONY-forming units assay ,PHARMACODYNAMICS - Abstract
Background In cryptococcal meningitis phase 2 clinical trials, early fungicidal activity (EFA) of Cryptococcus clearance from cerebrospinal fluid (CSF) is used as a surrogate endpoint for all-cause mortality. The Food and Drug Administration allows for using surrogate endpoints for accelerated regulatory approval, but EFA as a surrogate endpoint requires further validation. We examined the relationship between rate of CSF Cryptococcus clearance (EFA) and mortality through 18 weeks. Methods We pooled individual-level CSF data from 3 sequential cryptococcal meningitis clinical trials conducted during 2010–2017. All 738 subjects received amphotericin + fluconazole induction therapy and had serial quantitative CSF cultures. The log
10 -transformed colony-forming units (CFUs) per mL CSF were analyzed by general linear regression versus day of culture over the first 10 days. Results Mortality through 18 weeks was 37% for EFA > = 0.60 (n = 170), 36% for 0.40–0.59 (n = 182), 39% for 0.30–0.39 (n = 112), 35% for 0.20–0.29 (n = 87), and 50% for those with EFA < 0.20 CFU/mL/day (n = 187). The hazard ratio for 18-week mortality, comparing those with EFA < 0.20 to those with EFA > = 0.20, was 1.60 (95% confidence interval, 1.25, 2.04; P = .002). The lowest EFA group had lower median CD4 T-cell counts (P < .01) and lower proportion of patients with CSF pleocytosis (P < .001). Conclusions EFA is associated with all-cause mortality in cryptococcal meningitis. An EFA threshold of > = 0.20 log10 CFU/mL/day was associated with similar 18-week mortality (37%) compared to 50% mortality with EFA < 0.20. This EFA threshold may be considered a target for a surrogate endpoint. This builds upon existing studies to validate EFA as a surrogate endpoint. [ABSTRACT FROM AUTHOR]- Published
- 2020
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38. Cytomegalovirus Viremia Associated With Increased Mortality in Cryptococcal Meningitis in Sub-Saharan Africa.
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Skipper, Caleb, Schleiss, Mark R, Bangdiwala, Ananta S, Hernandez-Alvarado, Nelmary, Taseera, Kabanda, Nabeta, Henry W, Musubire, Abdu K, Lofgren, Sarah M, Wiesner, Darin L, Rhein, Joshua, Rajasingham, Radha, Schutz, Charlotte, Meintjes, Graeme, Muzoora, Conrad, Meya, David B, and Boulware, David R
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CEREBROSPINAL fluid ,CONFIDENCE intervals ,CRYPTOCOCCUS neoformans ,CYTOKINES ,CYTOMEGALOVIRUS diseases ,IMMUNOGLOBULINS ,LONGITUDINAL method ,MENINGITIS ,MULTIVARIATE analysis ,VIREMIA - Abstract
Background Cryptococcal meningitis and tuberculosis are both important causes of death in persons with advanced human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Cytomegalovirus (CMV) viremia may be associated with increased mortality in persons living with HIV who have tuberculosis. It is unknown whether concurrent CMV viremia is associated with mortality in other AIDS-related opportunistic infections. Methods We prospectively enrolled Ugandans living with HIV who had cryptococcal meningitis from 2010–2012. Subsequently, we analyzed stored baseline plasma samples from 111 subjects for CMV DNA. We compared 10-week survival rates among those with and without CMV viremia. Results Of 111 participants, 52% (58/111) had detectable CMV DNA (median plasma viral load 498 IU/mL, interquartile range [IQR] 259–2390). All samples tested were positive on immunoglobin G serology. The median CD4
+ T cell count was 19 cells/µL (IQR 9–70) and did not differ by the presence of CMV viremia (P =.47). The 10-week mortality rates were 40% (23/58) in those with CMV viremia and 21% (11/53) in those without CMV viremia (hazard ratio 2.19, 95% confidence interval [CI] 1.07–4.49; P =.03), which remained significant after a multivariate adjustment for known risk factors of mortality (adjusted hazard ratio 3.25, 95% CI 1.49–7.10; P =.003). Serum and cerebrospinal fluid cytokine levels were generally similar and cryptococcal antigen-specific immune stimulation responses did not differ between groups. Conclusions Half of persons with advanced AIDS and cryptococcal meningitis had detectable CMV viremia. CMV viremia was associated with an over 2-fold higher mortality rate. It remains unclear whether CMV viremia in severely immunocompromised persons with cryptococcal meningitis contributes directly to this mortality or may reflect an underlying immune dysfunction (ie, cause vs effect). Clinical Trials Registration NCT01075152. [ABSTRACT FROM AUTHOR]- Published
- 2020
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39. Symptoms of COVID-19 Outpatients in the United States.
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Pullen, Matthew F, Skipper, Caleb P, Hullsiek, Kathy H, Bangdiwala, Ananta S, Pastick, Katelyn A, Okafor, Elizabeth C, Lofgren, Sarah M, Rajasingham, Radha, Engen, Nicole W, Galdys, Alison, Williams, Darlisha A, Abassi, Mahsa, and Boulware, David R
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SYMPTOMS ,COVID-19 ,SARS-CoV-2 ,CLINICAL trials ,OUTPATIENTS - Abstract
Background Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel pathogen causing the current worldwide coronavirus disease 2019 (COVID-19) pandemic. Due to insufficient diagnostic testing in the United States, there is a need for clinical decision-making algorithms to guide testing prioritization. Methods We recruited participants nationwide for a randomized clinical trial. We categorized participants into 3 groups: (1) those with confirmed SARS-CoV-2 infection, (2) those with probable SARS-CoV-2 infection (pending test or not tested but with a confirmed COVID-19 contact), and (3) those with possible SARS-CoV-2 infection (pending test or not tested and with a contact for whom testing was pending or not performed). We compared the frequency of self-reported symptoms in each group and categorized those reporting symptoms in early infection (0–2 days), midinfection (3–5 days), and late infection (>5 days). Results Among 1252 symptomatic persons screened, 316 had confirmed, 393 had probable, and 543 had possible SARS-CoV-2 infection. In early infection, those with confirmed and probable SARS-CoV-2 infection shared similar symptom profiles, with fever most likely in confirmed cases (P = .002). Confirmed cases did not show any statistically significant differences compared with unconfirmed cases in symptom frequency at any time point. The most commonly reported symptoms in those with confirmed infection were cough (82%), fever (67%), fatigue (62%), and headache (60%), with only 52% reporting both fever and cough. Conclusions Symptomatic persons with probable SARS-CoV-2 infection present similarly to those with confirmed SARS-CoV-2 infection. There was no pattern of symptom frequency over time. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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40. Fetal Nasal Bone Length in the East African Population.
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Burn, Sabrina C., Markese, Amy, Bangdiwala, Ananta, Gill, Lisa, and Jacobs, Katherine
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NASAL bone ,FETAL ultrasonic imaging ,AFRICANS ,GESTATIONAL age ,AFRICAN Americans ,ULTRASONIC imaging ,LENGTH measurement - Abstract
Objectives: To establish normal ranges of fetal nasal bone length throughout gestation in the East African population and to subsequently compare these measurements with the standardized reference. Methods: A retrospective cross‐sectional study was performed at the University of Minnesota from January 2011 to December 2016. Fetal nasal bone length measurements were generated in a midsagittal plane at an angle of insonation of 45° from ultrasound images of 1407 nonanomalous fetuses of 1130 mothers of East African decent between 14 and 40 weeks' gestation. The proportion of fetal nasal bone lengths of less than 5.2 mm at week 20 of gestation in the East African population was then compared with the 5% noted by the standardized reference by a χ2 test. Results: The fetal nasal bone length increased linearly with advancing gestational age in fetuses of East African mothers (R2 = 0.53; P <.0001). The fetal nasal bone lengths of the East African fetuses were found to be shorter at all ages of gestation compared with the standard reference. At 20 weeks' gestation 17% (95% confidence interval, 13%–22%) of the nasal bone lengths of the East African fetuses were less than 5.2 mm compared with 5% of white and African American fetuses. Conclusions: Using the standard reference may lead to a greater than 3.5‐fold overdiagnosis of hypoplastic nasal bones in the East African population. To improve aneuploidy risk stratification and patient counseling in the East African population, the introduction of a standardized East African–based fetal nasal bone length reference seems warranted. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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41. Symptomatic Cryptococcal Antigenemia Presenting as Early Cryptococcal Meningitis With Negative Cerebral Spinal Fluid Analysis.
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Ssebambulidde, Kenneth, Bangdiwala, Ananta S, Kwizera, Richard, Kandole, Tadeo Kiiza, Tugume, Lillian, Kiggundu, Reuben, Mpoza, Edward, Nuwagira, Edwin, Williams, Darlisha A, Lofgren, Sarah M, Abassi, Mahsa, Musubire, Abdu K, Cresswell, Fiona V, Rhein, Joshua, Muzoora, Conrad, Hullsiek, Kathy Huppler, Boulware, David R, Meya, David B, and Team, Adjunctive Sertraline for Treatment of HIV-associated Cryptococcal Meningitis
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CELL culture , *CRYPTOCOCCUS , *CRYPTOCOCCUS neoformans , *FUNGAL antigens , *HOSPITAL care , *LEUCOCYTE disorders , *MENINGITIS , *MICROSCOPY , *POLYMERASE chain reaction , *CRYPTOCOCCOSIS , *HIV seroconversion , *HOSPITAL mortality , *SYMPTOMS , *DISEASE risk factors - Abstract
Background Individuals with cryptococcal antigenemia are at high risk of developing cryptococcal meningitis if untreated. The progression and timing from asymptomatic infection to cryptococcal meningitis is unclear. We describe a subpopulation of individuals with neurologic symptomatic cryptococcal antigenemia but negative cerebral spinal fluid (CSF) studies. Methods We evaluated 1201 human immunodeficiency virus–seropositive individuals hospitalized with suspected meningitis in Kampala and Mbarara, Uganda. Baseline characteristics and clinical outcomes of participants with neurologic–symptomatic cryptococcal antigenemia and negative CSF cryptococcal antigen (CrAg) were compared to participants with confirmed CSF CrAg+ cryptococcal meningitis. Additional CSF testing included microscopy, fungal culture, bacterial culture, tuberculosis culture, multiplex FilmArray polymerase chain reaction (PCR; Biofire), and Xpert MTB/Rif. Results We found 56% (671/1201) of participants had confirmed CSF CrAg+ cryptococcal meningitis and 4% (54/1201) had neurologic symptomatic cryptococcal antigenemia with negative CSF CrAg. Of those with negative CSF CrAg, 9% (5/54) had Cryptococcus isolated on CSF culture (n = 3) or PCR (n = 2) and 11% (6/54) had confirmed tuberculous meningitis. CSF CrAg-negative patients had lower proportions with CSF pleocytosis (16% vs 26% with ≥5 white cells/μL) and CSF opening pressure >200 mmH2O (16% vs 71%) compared with CSF CrAg-positive patients. No cases of bacterial or viral meningitis were detected by CSF PCR or culture. In-hospital mortality was similar between symptomatic cryptococcal antigenemia (32%) and cryptococcal meningitis (31%; P =.91). Conclusions Cryptococcal antigenemia with meningitis symptoms was the third most common meningitis etiology. We postulate this is early cryptococcal meningoencephalitis. Fluconazole monotherapy was suboptimal despite Cryptococcus -negative CSF. Further studies are warranted to understand the clinical course and optimal management of this distinct entity. Clinical Trials Registration NCT01802385. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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42. Absence of cerebrospinal fluid pleocytosis in tuberculous meningitis is a common occurrence in HIV co-infection and a predictor of poor outcomes
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Cresswell, Fiona V., Bangdiwala, Ananta S., Meya, David B., Bahr, Nathan C., Vidal, Jose E., Török, M. Estée, Thao, Le Thi Phuong, Thwaites, Guy E., and Boulware, David R.
- Published
- 2018
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43. Age alone is not a contraindication to kidney donation: Outcomes of donor nephrectomy in the elderly.
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Serrano, Oscar K., Yadav, Kunal, Bangdiwala, Ananta, Vock, David M., Dunn, Ty B., Finger, Erik B., Pruett, Timothy L., Matas, Arthur J., and Kandaswamy, Raja
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KIDNEY transplantation ,ORGAN donation ,NEPHRECTOMY ,OLDER patients ,GLOMERULAR filtration rate ,ABDOMINAL surgery - Abstract
Abstract: With increasing organ demand, living kidney donation from older donors (>60‐years‐old) has become more common. Between 1975 and 2014, 3752 donor nephrectomies (DN) were performed at University of Minnesota; 167 (4.5%) were >60‐years‐old Short‐ and long‐term outcomes were compared between contemporaneous >60‐years‐old and <60‐years‐old donors. On univariate analysis, >60‐years‐old were more likely to have had prior abdominal surgery and hypertension; and less likely to smoke. Baseline estimated glomerular filtration rate (eGFR) was lower in >60‐years‐old (80 ± 16 vs 101 ± 26 mL/min/1.73 m
2 ; P < .001). Intraoperative and postoperative complications were similar, except a higher prevalence of <30 day ileus (3% vs 7%; P = .021) and longer postoperative length of stay (LOS) (4.2 vs 4.6 days; P = .005). On multivariate analysis, <30 day ileus and LOS continued to be significantly greater for >60‐years‐old After >20 years post‐DN, systolic blood pressure was significantly higher among >60‐years‐old (142 vs 125 mm Hg; P < .001) and HTN was diagnosed earlier (9 vs 14 years). After donation, eGFR was significantly lower for >60‐years‐old but slope of eGFR and rates of end‐stage renal disease (ESRD) were not significantly different >20 years post‐DN. Thus, kidney donation among carefully selected >60‐years‐old poses minimal perioperative risks and no added risk of long‐term ESRD. [ABSTRACT FROM AUTHOR]- Published
- 2018
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44. Clinical Significance of Pulmonary Nodules in the Pretransplant Evaluation of Liver Transplant Recipients With Hepatocellular Carcinoma.
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Serrano, Oscar K., Olgun, Deniz C., Goduguchinta, Varshita, Bangdiwala, Ananta, Odegard, Marjorie N., Kandaswamy, Raja, Matas, Arthur J., Lake, John R., Pruett, Timothy L., and Chinnakotla, Srinath
- Published
- 2018
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45. 426: Neonatal morbidity and complication rates in the super-super-obese
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Kim, Tana, Burn, Sabrina C., Bangdiwala, Ananta, Pace, Samantha, Rauk, Phillip N., and Lupo, Virginia R.
- Published
- 2017
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46. 287: Exploratory research on first and second trimester urinary metabolic profiles and fetal growth restriction
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Luthra, Gauri, Vuckovic, Ivan, Redmon, J. Bruce, Gray, Heather, Bangdiwala, Ananta, Shields, Andrea, Macura, Slobodan, and Nair, K. Sreekumaran
- Published
- 2017
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47. Estimating Survival in Patients With Lung Cancer and Brain Metastases: An Update of the Graded Prognostic Assessment for Lung Cancer Using Molecular Markers (Lung-molGPA).
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Sperduto, Paul W., Yang, T. Jonathan, Beal, Kathryn, Pan, Hubert, Brown, Paul D., Bangdiwala, Ananta, Shanley, Ryan, Yeh, Norman, Gaspar, Laurie E., Braunstein, Steve, Sneed, Penny, Boyle, John, Kirkpatrick, John P., Mak, Kimberley S., Shih, Helen A., Engelman, Alex, Roberge, David, Arvold, Nils D., Alexander, Brian, and Awad, Mark M.
- Published
- 2017
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48. Infection rates in tacrolimus versus cyclosporine-treated pediatric kidney transplant recipients on a rapid discontinuation of prednisone protocol: 1-year analysis.
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Kizilbash, Sarah J., Rheault, Michelle N., Bangdiwala, Ananta, Matas, Arthur, Chinnakotla, Srinath, and Chavers, Blanche M.
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TACROLIMUS ,CYCLOSPORINE ,KIDNEY transplant patients ,PREDNISONE ,KIDNEY transplant complications ,SURVIVAL analysis (Biometry) - Abstract
AR is lower in pKTx recipients on Tac vs CsA. Data comparing infection outcomes for children treated with these agents are limited. We retrospectively studied infection outcomes in 96 pKTx recipients on a RDP. PS, DCGS, AR, and infection-free survival were assessed using Kaplan-Meier/log-rank tests and proportional hazards models. There were no differences in 1-year PS, DCGS, or AR between Tac and CsA recipients. After adjusting for AR, the hazard of CMV viremia was 4.0 times higher (95% CI: 1.04, 15.5; P = .044) and that of BK viremia was 3.8 times higher (95% CI: 1.5, 10.2; P = .007) in Tac recipients. The incidence of EBV viremia was similar between the groups ( P = .56). PostTx lymphoproliferative disease was only observed in Tac recipients (3%). There was no difference in the incidence of pneumonia, urinary tract, or Clostridium difficile infections between Tac and CsA recipients. Among KTx recipients on RDP, the hazards of CMV and BK viremia within 1 year post- KTx were significantly higher in Tac recipients compared to CsA. Regular assessment for infections and lower Tac trough levels may be warranted in Tac recipients. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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49. Delineating Optimal Surgical Performance in Laparoscopic Donor Nephrectomy among Transplant Surgery Fellows: A Learning Curve Analysis
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Serrano, Oscar K., Bangdiwala, Ananta, Vock, David, Kirchner, Varvara A., Berglund, Danielle, Dunn, Ty B., Finger, Erik, Pruett, Timothy L., Matas, Arthur J., and Kandaswamy, Raja
- Published
- 2016
- Full Text
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50. Risk Factors for Developing Adult Cardiovascular Disease in Children Who Received a Kidney Transplant: Analysis of 1,055 Kidney Transplants between 1963-2015 at a Single Institution
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Serrano, Oscar K., Bangdiwala, Ananta, Vock, David, Dunn, Ty B., Chinnakotla, Srinath, Finger, Erik, Kandaswamy, Raja, Pruett, Timothy L., Matas, Arthur J., and Chavers, Blanche
- Published
- 2016
- Full Text
- View/download PDF
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