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1. Systematic Review of Prevalence of Histoplasma Antigenuria in Persons with HIV in Latin America and Africa

Author

Sekar, Preethiya, Hale, Gila, Gakuru, Jane, Meya, David B., Boulware, David R., Ellis, Jayne, Nalintya, Elizabeth, Bahr, Nathan C., and Rajasingham, Radha

Subjects
Urine -- Analysis, Antigens -- Measurement -- Health aspects, Histoplasmosis -- Statistics -- Risk factors -- Diagnosis, HIV patients -- Statistics, Immunologic diseases -- Statistics -- Risk factors -- Diagnosis
Abstract

Histoplasmosis is an endemic fungal infection caused by Histoplasma capsulatum. In immunocompetent persons, histoplasmosis is often asymptomatic or localized to the pulmonary system. However, in immunocompromised persons, histoplasmosis can manifest [...]

Published
2024
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4. Global guideline for the diagnosis and management of cryptococcosis: an initiative of the ECMM and ISHAM in cooperation with the ASM

Author

Chang, Christina C, Harrison, Thomas S, Bicanic, Tihana A, Chayakulkeeree, Methee, Sorrell, Tania C, Warris, Adilia, Hagen, Ferry, Spec, Andrej, Oladele, Rita, Govender, Nelesh P, Chen, Sharon C, Mody, Christopher H, Groll, Andreas H, Chen, Yee-Chun, Lionakis, Michail S, Alanio, Alexandre, Castañeda, Elizabeth, Lizarazo, Jairo, Vidal, José E, Takazono, Takahiro, Hoenigl, Martin, Alffenaar, Jan-Willem, Gangneux, Jean-Pierre, Soman, Rajeev, Zhu, Li-Ping, Bonifaz, Alexandro, Jarvis, Joseph N, Day, Jeremy N, Klimko, Nikolai, Salmanton-García, Jon, Jouvion, Grégory, Meya, David B, Lawrence, David, Rahn, Sebastian, Bongomin, Felix, McMullan, Brendan J, Sprute, Rosanne, Nyazika, Tinashe K, Beardsley, Justin, Carlesse, Fabianne, Heath, Christopher H, Ayanlowo, Olusola O, Mashedi, Olga M, Queiroz-Telles Filho, Flavio, Hosseinipour, Mina C, Patel, Atul K, Temfack, Elvis, Singh, Nina, Cornely, Oliver A, Boulware, David R, Lortholary, Olivier, Pappas, Peter G, and Perfect, John R

Published
2024
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5. Noninvasive Testing and Surrogate Markers in Invasive Fungal Diseases

Author

Thompson, George R, Boulware, David R, Bahr, Nathan C, Clancy, Cornelius J, Harrison, Thomas S, Kauffman, Carol A, Le, Thuy, Miceli, Marisa H, Mylonakis, Eleftherios, Nguyen, M Hong, Ostrosky-Zeichner, Luis, Patterson, Thomas F, Perfect, John R, Spec, Andrej, Kontoyiannis, Dimitrios P, and Pappas, Peter G

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Emerging Infectious Diseases, Prevention, Infectious Diseases, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Infection, Good Health and Well Being, diagnosis, fungal infections, mycology, Clinical sciences, Medical microbiology
Abstract

Invasive fungal infections continue to increase as at-risk populations expand. The high associated morbidity and mortality with fungal diseases mandate the continued investigation of novel antifungal agents and diagnostic strategies that include surrogate biomarkers. Biologic markers of disease are useful prognostic indicators during clinical care, and their use in place of traditional survival end points may allow for more rapid conduct of clinical trials requiring fewer participants, decreased trial expense, and limited need for long-term follow-up. A number of fungal biomarkers have been developed and extensively evaluated in prospective clinical trials and small series. We examine the evidence for these surrogate biomarkers in this review and provide recommendations for clinicians and regulatory authorities.

Published
2022

7. Cryptococcal meningitis

Author

Tugume, Lillian, Ssebambulidde, Kenneth, Kasibante, John, Ellis, Jayne, Wake, Rachel M., Gakuru, Jane, Lawrence, David S., Abassi, Mahsa, Rajasingham, Radha, Meya, David B., and Boulware, David R.

Published
2023
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8. Fluvoxamine for the Early Treatment of SARS-CoV-2 Infection: A Review of Current Evidence

Author

Facente, Shelley N, Reiersen, Angela M, Lenze, Eric J, Boulware, David R, and Klausner, Jeffrey D

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Emerging Infectious Diseases, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Animals, COVID-19, Clinical Deterioration, Evidence-Based Medicine, Fluvoxamine, Host-Pathogen Interactions, Humans, Randomized Controlled Trials as Topic, Research Design, SARS-CoV-2, Selective Serotonin Reuptake Inhibitors, Treatment Outcome, COVID-19 Drug Treatment, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Clinical sciences, Pharmacology and pharmaceutical sciences
Abstract

SARS-CoV-2 infection causes COVID-19, which frequently leads to clinical deterioration and/or long-lasting morbidity. Academic and governmental experts throughout the USA met in 2021 to discuss the potential for use of fluvoxamine as early treatment of SARS-CoV-2 infection. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is a strong sigma-1 receptor agonist, and this may effectively reduce cytokine production, preventing clinical deterioration. This repurposed psychiatric medication has a well-known safety record, is inexpensive, easy to use, and widely available, all of which are advantages during this global COVID-19 pandemic. At the meeting, experts reviewed the existing published literature on the use of fluvoxamine as experimental COVID-19 treatment, as well as prior research on the potential mechanisms for anti-inflammatory effects of fluvoxamine, including for other conditions including sepsis. Investigators shared current trials underway and existing gaps in knowledge. Two randomized controlled trials and one observational study examining the effect of fluvoxamine in COVID-19 treatment have found high efficacy. Four larger randomized clinical trials are currently underway, including three in the USA and Canada. More data are needed on dosing and mechanisms of effect; however, fluvoxamine appears to have substantial potential as a safe and widely available medication that could be repurposed to ameliorate serious COVID-19-related morbidity and mortality. As of April 2021, fluvoxamine was mentioned in the NIH COVID-19 treatment guidelines, although no recommendation is made for or against use. Available data may warrant clinician discussion of fluvoxamine as a treatment option for COVID-19, using shared decision making. Video Abstract.

Published
2021

9. Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial

Author

Anderson, Blake, Atwater, Riannon C, Avula, Nandini, Beckman, Kenny B, Belani, Hrishikesh K, Boulware, David R, Bramante, Carolyn T, Brea, Jannis, Broedlow, Courtney A, Buse, John B, Campora, Paula, Challa, Anup, Charles, Jill, Christensen, Grace, Christiansen, Theresa, Cohen, Ken, Connelly, Bo, Datta, Srijani, Deng, Nikita, Dunn, Alex T, Erickson, Spencer M, Fairbairn, Faith M, Fenno, Sarah L, Fraser, Daniel J, Fricton, Regina D, Griffiths, Gwen, Hagen, Aubrey A, Hartman, Katrina M, Hendrickson, Audrey F, Huling, Jared D, Ingraham, Nicholas E, Jeng, Arthur C, Johnson, Darrell M, Karger, Amy B, Klatt, Nichole R, Kuehl, Erik A, LaBar, Derek D, Lee, Samuel, Liebovitz, David M, Lindberg, Sarah, Luke, Darlette G, Machicado, Rosario, Mohamud, Zeinab, Murray, Thomas A, Ngonyama, Rumbidzai, Nicklas, Jacinda M, Odde, David J, Parrens, Elliott, Parra, Daniela, Patel, Barkha, Proper, Jennifer L, Pullen, Matthew F, Puskarich, Michael A, Rao, Via, Reddy, Neha V, Reddy, Naveen, Rypka, Katelyn J, Saveraid, Hanna G, Seloadji, Paula, Shahriar, Arman, Sherwood, Nancy, Siegart, Jamie L, Siegel, Lianne K, Simmons, Lucas, Sinelli, Isabella, Singh, Palak, Snyder, Andrew, Stauffer, Maxwell T, Thompson, Jennifer, Tignanelli, Christopher J, Tople, Tannon L, Tordsen, Walker J, Watson, Ray HB, Wu, Beiqing, Zaman, Adnin, Zolik, Madeline R, Zinkl, Lena, Anderson, Blake J, Thompson, Jennifer L, Pullen, Matthew, Wirtz, Esteban Lemus, Sherwood, Nancy E, Lindberg, Sarah M, Beckman, Kenneth B, Rose, Michael R, Mehta, Tanvi, Griffiths, Gwendolyn, and Bhat, Neeta S

Published
2023
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11. Xpert MTB/RIF Ultra for the Diagnosis of Tuberculous Meningitis: A Small Step Forward

Author

Donovan, Joseph, Cresswell, Fiona V, Thuong, Nguyen Thuy Thuong, Boulware, David R, Thwaites, Guy E, Bahr, Nathan C, Aarnoutse, Rob E, Anderson, Suzanne TB, Bang, Nguyen D, Boyles, Tom, te Brake, Lindsey HM, Chandra, Satish, Chow, Felicia C, van Crevel, Reinout, Davis, Angharad G, Dian, Sofiati, Dooley, Kelly E, Figaji, Anthony, Ganiem, A Rizal, Garg, Ravindra Kumar, Gibb, Diana M, Hamers, Raph L, Hiep, Nguyen TT, Imran, Darma, Imron, Akhmad, Jain, Sanjay K, Jain, Sunil K, Kalita, Jayantee, Kumar, Rashmi, Kumar, Vinod, van Laarhoven, Arjan, Lai, Rachel P-J, Manesh, Abi, Marais, Suzaan, Mave, Vidya, Meintjes, Graeme, Meya, David B, Misra, Usha K, Modi, Manish, Ordonez, Alvaro A, Phu, Nguyen H, Pradhan, Sunil, Prasad, Kameshwar, Proust, Alize M, Ramakrishnan, Lalita, Rohlwink, Ursula, Ruslami, Rovina, Schoeman, Johannes F, Seddon, James A, Sharma, Kusum, Siddiqi, Omar, Solomons, Regan S, Thuong, Nguyen TT, van Toorn, Ronald, Tucker, Elizabeth W, Wasserman, Sean A, and Wilkinson, Robert J

Subjects
Rare Diseases, Tuberculosis, Infectious Diseases, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Good Health and Well Being, Diagnostic Tests, Routine, Humans, Molecular Diagnostic Techniques, Mycobacterium tuberculosis, Sensitivity and Specificity, Tuberculosis, Meningeal, Tuberculous Meningitis International Research Consortium, Ultra, Xpert, cerebrospinal fluid, diagnosis, tuberculous meningitis, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

The delayed diagnosis of tuberculous meningitis (TBM) leads to poor outcomes, yet the current diagnostic methods for identifying Mycobacterium tuberculosis in cerebrospinal fluid (CSF) are inadequate. The first comparative study of the new GeneXpert MTB/RIF Ultra (Xpert Ultra) for TBM diagnosis suggested increased sensitivity of Xpert Ultra. Two subsequent studies have shown Xpert Ultra has improved sensitivity, but has insufficient negative predictive value to exclude TBM. Collecting and processing large volumes of CSF for mycobacterial testing are important for optimal diagnostic test performance. But clinical, radiological, and laboratory parameters remain essential for TBM diagnosis and empiric therapy is often needed. We therefore caution against the use of Xpert Ultra as a single diagnostic test for TBM; it cannot be used to "rule out" TBM.

Published
2020

12. Cost-effectiveness of single, high-dose, liposomal amphotericin regimen for HIV-associated cryptococcal meningitis in five countries in sub-Saharan Africa: an economic analysis of the AMBITION-cm trial

Author

Goodall, Jack, Lechiile, Kwana, Mawoko, Norah, Mbangiwa, Tshepiso, Milburn, James, Mmipi, Refilwe, Ponatshego, Ponego, Rulaganyang, Ikanyang, Seatla, Kaelo, Siamisang, Keatlaretse, Tlhako, Nametso, Tsholo, Katlego, April, Samantha, Bekiswa, Abulele, Boloko, Linda, Bookholane, Hloni, Crede, Thomas, Davids, Lee-Ann, Goliath, Rene, Hlungulu, Siphokazi, Hoffman, Regina, Kyepa, Henriette, Masina, Noma, Maughan, Deborah, Mnguni, Trevor, Moosa, Sumaiyya, Morar, Tania, Mpalali, Mkanyiseli, Naude, Jonathan, Oliphant, Ida, Singh, Achita, Sayed, Sumaya, Sebesho, Leago, Shey, Muki, Swanepoel, Loraine, Chasweka, Madalitso, Chimang'anga, Wezi, Chimphambano, Tipatseni, Gondwe, Ebbie, Mzinganjira, Henry, Kadzilimbile, Aubrey, Kateta, Steven, Kossam, Evelyn, Kukacha, Christopher, Lipenga, Bright, Ndaferankhande, John, Ndalama, Maureen, Shah, Reya, Singini, Andreas, Stott, Katherine, Zambasa, Agness, Banda, Towera, Chikaonda, Tarsizio, Chitulo, Gladys, Chiwoko, Lorren, Chome, Nelecy, Gwin, Mary, Kachitosi, Timothy, Kamanga, Beauty, Kazembe, Mussah, Kumwenda, Emily, Kumwenda, Masida, Maya, Chimwemwe, Mhango, Wilberforce, Mphande, Chimwemwe, Msumba, Lusungu, Munthali, Tapiwa, Ngoma, Doris, Nicholas, Simon, Simwinga, Lusayo, Stambuli, Anthony, Tegha, Gerald, Zambezi, Janet, Ahimbisibwe, Cynthia, Akampurira, Andrew, Alice, Anamudde, Cresswell, Fiona, Gakuru, Jane, Kagimu, Enock, Kasibante, John, Kiiza, Daniel, Kisembo, John, Kwizera, Richard, Kugonza, Florence, Laker, Eva, Luggya, Tonny, Lule, Andrew, Musubire, Abdu, Muyise, Rhona, Namujju, Carol Olivie, Ndyetukira, Jane Francis, Nsangi, Laura, Okirworth, Michael, Rhein, Joshua, Rutakingirwa, Morris K, Sadiq, Alisat, Ssebambulidde, Kenneth, Tadeo, Kiiza, Tukundane, Asmus, Atwine, Leo, Buzaare, Peter, Collins, Muganzi, Emily, Ninsima, Inyakuwa, Christine, Kariisa, Samson, Mwesigye, James, Nuwamanya, Simpson, Rodgers, Ankunda, Rukundo, Joan, Rwomushana, Irene, Ssemusu, Mike, Stead, Gavin, Boyd, Kathyrn, Gondo, Secrecy, Kufa, Prosper, Makaha, Edward, Moyo, Colombus, Mtisi, Takudzwa, Mudzinga, Shepherd, Mutata, Constantine, Mwarumba, Taddy, Zinyandu, Tawanda, Alanio, Alexandre, Dromer, Francoise, Lortholary, Olivier, Sturny-Leclere, Aude, Griffin, Philippa, Hafeez, Sophia, Loyse, Angela, van Widenfelt, Erik, Lawrence, David S, Muthoga, Charles, Meya, David B, Tugume, Lillian, Williams, Darlisha, Rajasingham, Radha, Boulware, David R, Mwandumba, Henry C, Moyo, Melanie, Dziwani, Eltas N, Maheswaran, Hendramoorthy, Kanyama, Cecilia, Hosseinipour, Mina C, Chawinga, Chimwemwe, Meintjes, Graeme, Schutz, Charlotte, Comins, Kyla, Bango, Funeka, Muzoora, Conrad, Jjunju, Samuel, Nuwagira, Edwin, Mosepele, Mosepele, Leeme, Tshepo, Ndhlovu, Chiratidzo E, Hlupeni, Admire, Shamu, Shepherd, Boyer-Chammard, Timothée, Molloy, Síle F, Youssouf, Nabila, Chen, Tao, Shiri, Tinevimbo, Jaffar, Shabbar, Harrison, Thomas S, Jarvis, Joseph N, and Niessen, Louis W

Published
2022
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14. Neurocognitive and functional impairment in adult and paediatric tuberculous meningitis

Author

Davis, Angharad G, Nightingale, Sam, Springer, Priscilla E, Solomons, Regan, Arenivas, Ana, Wilkinson, Robert J, Anderson, Suzanne T, Chow, Felicia C, Aarnoutse, Rob E, Anderson, Suzanne TB, Bahr, Nathan C, Bang, Nguyen D, Boulware, David R, Boyles, Tom, Brake, Lindsey HM te, Chandra, Satish, Cresswell, Fiona V, van Crevel, Reinout, Dian, Sofiati, Donovan, Joseph, Dooley, Kelly E, Figaji, Anthony, Ganiem, A Rizal, Garg, Ravindra Kumar, Gibb, Diana M, Hamers, Raph L, Hiep, Nguyen TT, Imran, Darma, Imron, Akhmad, Jain, Sanjay K, Jain, Sunil K, Jeejeebhoy, Byramee, Kalita, Jayantee, Kumar, Rashmi, Kumar, Vinod, van Laarhoven, Arjan, Lai, Rachel P-J, Manesh, Abi, Marais, Suzaan, Mave, Vidya, Meintjes, Graeme, Meya, David B, Misra, Usha K, Modi, Manish, Ordonez, Alvaro A, Phu, Nguyen H, Pradhan, Sunil, Prasad, Kameshwar, Proust, Alize M, Ramakrishnan, Lalita, Rohlwink, Ursula, Ruslami, Rovina, Schoeman, Johannes F, Seddon, James A, Sharma, Kusum, Siddiqi, Omar, Solomons, Regan S, Thuong, Nguyen TT, Thwaites, Guy E, van Toorn, Ronald, Tucker, Elizabeth W, and Wasserman, Sean A

Subjects
Biomedical and Clinical Sciences, Health Sciences, Neurosciences, Brain Disorders, Behavioral and Social Science, Mental health, Good Health and Well Being, Tuberculous Meningitis International Research Consortium, Functional, Neurobehavioural, Neurocognitive, Neurodevelopmental, Psychiatric, Tuberculous Meningitis, Biomedical and clinical sciences, Health sciences
Abstract

In those who survive tuberculous meningitis (TBM), the long-term outcome is uncertain; individuals may suffer neurocognitive, functional and psychiatric impairment, which may significantly affect their ability to lead their lives as they did prior to their diagnosis of TBM. In children who survive, severe illness has occurred at a crucial timepoint in their development, which can lead to behavioural and cognitive delay. The extent and nature of this impairment is poorly understood, particularly in adults. This is in part due to a lack of observational studies in this area but also inconsistent inclusion of outcome measures which can quantify these deficits in clinical studies. This leads to a paucity of appropriate rehabilitative therapies available for these individuals and their caregivers, as well as burden at a socioeconomic level. In this review, we discuss what is known about neurocognitive impairment in TBM, draw on lessons learnt from other neurological infections and discuss currently available and emerging tools to evaluate function and cognition and their value in TBM. We make recommendations on which measures should be used at what timepoints to assess for impairment, with a view to optimising and standardising assessment of neurocognitive and functional impairment in TBM research.

Published
2019

15. Standardized approaches for clinical sampling and endpoint ascertainment in tuberculous meningitis studies

Author

Rohlwink, Ursula K, Chow, Felicia C, Wasserman, Sean, Dian, Sofiati, Lai, Rachel PJ, Chaidir, Lidya, Hamers, Raph L, Wilkinson, Robert J, Boulware, David R, Cresswell, Fiona V, and van Laarhoven, Arjan

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Good Health and Well Being, Tuberculous Meningitis International Research Consortium, endpoints, imaging, immunology, metabolomics, microbiology, outcome, proteomics, sampling, tuberculous meningitis, Biomedical and clinical sciences, Health sciences
Abstract

Tuberculous meningitis (TBM), the most severe manifestation of tuberculosis, has poorly understood immunopathology and high mortality and morbidity despite antituberculous therapy. This calls for accelerated clinical and basic science research in this field. As TBM disproportionally affects poorer communities, studies are often performed in resource-limited environments, creating challenges for data collection and harmonisation. Comparison of TBM studies has been hampered by variation in sampling strategies, study design and choice of study endpoints.  Based on literature review and expert consensus, this paper provides firstly, practical recommendations to enable thorough diagnostic, pathophysiological and pharmacokinetic studies using clinical samples, and facilitates better data aggregation and comparisons across populations and settings. Secondly, we discuss clinically relevant study endpoints, including neuroimaging, functional outcome, and cause of death, with suggestions of how these could be applied in different designs for future TBM studies.

Published
2019

16. Establishing the cascade of care for patients with tuberculous meningitis

Author

Imran, Darma, Hill, Philip C, McKnight, Jacob, van Crevel, Reinout, Aarnoutse, Rob E, Anderson, Suzanne TB, Bahr, Nathan C, Bang, Nguyen D, Boulware, David R, Boyles, Tom, Brake, Lindsey HM te, Chandra, Satish, Chow, Felicia C, Cresswell, Fiona V, Davis, Angharad G, Dian, Sofiati, Donovan, Joseph, Dooley, Kelly E, Figaji, Anthony, Ganiem, A Rizal, Garg, Ravindra Kumar, Gibb, Diana M, Hamers, Raph L, Hiep, Nguyen TT, Imron, Akhmad, Jain, Sanjay K, Jain, Sunil K, Jeejeebhoy, Byramee, Kalita, Jayantee, Kumar, Rashmi, Kumar, Vinod, van Laarhoven, Arjan, Lai, Rachel P-J, Manesh, Abi, Marais, Suzaan, Mave, Vidya, Meintjes, Graeme, Meya, David B, Misra, Usha K, Modi, Manish, Ordonez, Alvaro A, Phu, Nguyen H, Pradhan, Sunil, Prasad, Kameshwar, Proust, Alize M, Ramakrishnan, Lalita, Rohlwink, Ursula, Ruslami, Rovina, Schoeman, Johannes F, Seddon, James A, Sharma, Kusum, Siddiqi, Omar, Solomons, Regan S, Thuong, Nguyen TT, Thwaites, Guy E, van Toorn, Ronald, Tucker, Elizabeth W, Wasserman, Sean A, and Wilkinson, Robert J

Subjects
Health Services and Systems, Biomedical and Clinical Sciences, Health Sciences, Infectious Diseases, Health Services, Tuberculosis, HIV/AIDS, Clinical Research, Rare Diseases, 8.1 Organisation and delivery of services, Health and social care services research, Infection, Good Health and Well Being, Tuberculous Meningitis International Research Consortium, cascade of care, health systems, meningitis, patient pathway analysis, tuberculosis, Biomedical and clinical sciences, Health sciences
Abstract

Meningitis is a relatively rare form of tuberculosis, but it carries a high mortality rate, reaching 50% in some settings, with higher rates among patients with HIV co-infection and those with drug-resistant disease. Most studies of tuberculosis meningitis (TBM) tend to focus on better diagnosis, drug treatment and supportive care for patients in hospital. However, there is significant variability in mortality between settings, which may be due to specific variation in the availability and quality of health care services, both prior to, during, and after hospitalization. Such variations have not been studied thoroughly, and we therefore present a theoretical framework that may help to identify where efforts should be focused in providing optimal services for TBM patients. As a first step, we propose an adjusted cascade of care for TBM and patient pathway studies that might help identify factors that account for losses and delays across the cascade. Many of the possible gaps in the TBM cascade are related to health systems factors; we have selected nine domains and provide relevant examples of systems factors for TBM for each of these domains that could be the basis for a health needs assessment to address such gaps. Finally, we suggest some immediate action that could be taken to help make improvements in services. Our theoretical framework will hopefully lead to more health system research and improved care for patients suffering from this most dangerous form of tuberculosis.

Published
2019

17. Cytomegalovirus viremia as a risk factor for mortality in HIV-associated cryptococcal and tuberculous meningitis

Author

Skipper, Caleb P., Hullsiek, Katherine Huppler, Cresswell, Fiona V., Tadeo, Kiiza K., Okirwoth, Michael, Blackstad, Mark, Hernandez-Alvarado, Nelmary, Fernández-Alarcón, Claudia, Walukaga, Stewart, Martyn, Emily, Ellis, Jayne, Ssebambulidde, Kenneth, Tugume, Lillian, Nuwagira, Edwin, Rhein, Joshua, Meya, David B., Boulware, David R., and Schleiss, Mark R.

Published
2022
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19. Baseline C-reactive Protein as a Risk Factor for Cryptococcal Meningitis and Death in HIV-associated Cryptococcal Antigenemia With CrAg Titer as an Effect Modifier.

Author

Skipper, Caleb P, Kirumira, Paul, Dai, Biyue, Wele, Abduljewad, Naluyima, Rose, Namuli, Teopista, Turya, Fred, Muhumuza, Patrick, Kibengo, Freddie, Boulware, David R, Meya, David B, Nalintya, Elizabeth, and Rajasingham, Radha

Subjects
BLOOD proteins, C-reactive protein, ODDS ratio, LOGISTIC regression analysis, TITERS
Abstract

Background Persons with HIV and cryptococcal antigenemia are at high risk of progression to cryptococcal meningitis or death. Baseline cryptococcal antigen (CrAg) plasma titer ≥1:160 is a known risk factor for poor outcomes, but other risk factors are unknown. In HIV-associated cryptococcal meningitis, baseline serum C-reactive protein (CRP) concentrations are positively associated with increased mortality. We hypothesized that CRP might also be associated with meningitis or death in persons with cryptococcal antigenemia. Methods We measured plasma CrAg titers and CRP concentrations on cryopreserved serum from prospectively enrolled persons with HIV and cryptococcal antigenemia. Using time-to-event analyses, we compared 24-week meningitis-free survival in persons with normal CRP (<8 mg/L) and elevated CRP (≥8 mg/L). Logistic regression was used to assess how CRP concentration and CrAg titer might interact as covariates. Results Of the 94 persons with elevated CRP, 19 (20.2%) developed meningitis or death, whereas of the 88 persons with normal CRP, 8 (9.1%) developed meningitis or death (P =.035). Persons with CrAg titer <1:160 and normal CRP had an ∼5% (3/61) event rate, whereas those with CrAg titer <1:160 but elevated CRP had an ∼20% (12/59) event rate. Importantly, we identified a statistically significant interaction effect between CrAg titer and CRP groups, in which elevated CRP increased risk in the low CrAg titer group (odds ratio, 1.54; 95% confidence interval, 1.16–2.04), but this effect was not present in high CrAg titer group (odds ratio, 0.78; 95% confidence interval,.53–1.15). Conclusions Our findings demonstrate that CrAg titer may modify the direction of effect of CRP with meningitis-free survival; future studies should account for this interaction. [ABSTRACT FROM AUTHOR]

Published
2024
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20. A Comparison of Recruitment Methods for a Remote, Nationwide Clinical Trial for Covid-19 Treatment

Author

Hartman, Katrina M, primary, Patel, Barkha, additional, Rao, Via, additional, Hagen, Aubrey A, additional, Saveraid, Hanna G, additional, Fricton, Regina, additional, Lee, Samuel, additional, Snyder, Andrew T, additional, Pullen, Matthew F, additional, Boulware, David R, additional, Liebovitz, David M, additional, Belani, Hrishikesh K, additional, Niklas, Jacinda M, additional, Murray, Thomas A, additional, Cohen, Ken, additional, Thompson, Jennifer L, additional, Erickson, Spencer M, additional, and Bramante, Carolyn T, additional

Published
2024
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24. Sex-specific associations between cerebrospinal fluid inflammatory marker levels and cognitive function in antiretroviral treated people living with HIV in rural Uganda

Author

Vecchio, Alyssa C., Williams, Dionna W., Xu, Yanxun, Yu, Danyang, Saylor, Deanna, Lofgren, Sarah, O'Toole, Riley, Boulware, David R., Nakasujja, Noeline, Nakigozi, Gertrude, Kisakye, Alice, Batte, James, Mayanja, Richard, Anok, Aggrey, Reynolds, Steven J., Quinn, Thomas C., Gray, Ronald H., Wawer, Maria J., Sacktor, Ned, and Rubin, Leah H.

Published
2021
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26. Mid–Upper Arm Circumference Is a Strong Predictor of Mortality Among Ugandan Adults With HIV-Associated Cryptococcal Meningitis: A Prospective Cohort Study.

Author

Hale, Gila, Adzemovic, Tessa, Hullsiek, Kathy Huppler, Mulwana, Suzan, Ndyetukira, Jane Francis, Sadiq, Alisat, Kabahubya, Mable, Ayebare, Peruth, Nankungu, Lydia, Namudde, Alice, Namanda, Sylvia, Menya, Grace, Nakitto, Grace, Muzoora, Conrad, Nuwagira, Edwin, Rhein, Joshua, Meya, David B, Boulware, David R, Ellis, Jayne, and Abassi, Mahsa

Subjects
ARM circumference, MORTALITY risk factors, CD4 lymphocyte count, ANTIRETROVIRAL agents, COHORT analysis
Abstract

Background Mortality among adults diagnosed with HIV-associated cryptococcal meningitis remains high (24%–40%). We hypothesized that nutritional state, as measured by mid–upper arm circumference (MUAC), is a potentially modifiable risk factor for mortality. Methods Ugandan adults hospitalized with HIV-associated cryptococcal meningitis had MUAC measurements performed at baseline. We compared MUAC measurements with baseline clinical and demographic variables and investigated associations with survival using Cox regression. Results Of 433 participants enrolled, 41% were female, the median CD4 T-cell count (interquartile range [IQR]) was 15 (6–41) cells/μL, and 37% were antiretroviral therapy naïve. The median MUAC (IQR) was 24 (22–26) cm, the median weight (IQR) was 53 (50–60) kg, and MUAC correlated with weight (Pearson r = 0.6; P <.001). Overall, 46% (200/433) died during the 18-week follow-up. Participants in the lowest MUAC quartile (≤22 cm) had the highest mortality: 39% (46/118) at 2 weeks and 62% (73/118) at 18 weeks. A baseline MUAC ≤22 cm was associated with an 82% increased risk of 18-week mortality as compared with participants with an MUAC >22 cm (unadjusted hazard ratio, 1.82; 95% CI, 1.36–2.42; P <.001). Following adjustment for antiretroviral therapy status, CD4 count, hemoglobin, amphotericin dose, and tuberculosis status, the adjusted hazard ratio was 1.84 (95% CI, 1.27–2.65; P <.001). As a continuous variable, 18-week mortality was reduced by 10% for every 1-cm increase in MUAC. CSF Th17 immune responses were positively associated with MUAC quartile. Conclusions MUAC measurement is a simple bedside tool that can identify adults with HIV-associated cryptococcal meningitis at high risk for mortality for whom an enhanced bundle of care, including nutritional supplementation, should be further investigated. [ABSTRACT FROM AUTHOR]

Published
2024
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27. When Someone Should Do Something About This: How a Cryptococcal Clinical Trialist Became Involved With the COVID-19 Pandemic.

Author

Boulware, David R

Subjects
*HYDROXYCHLOROQUINE, *WORK, *COVID-19 testing, *RANDOMIZED controlled trials, *PHYSICIANS' attitudes, *RESEARCH protocols, *PRE-exposure prophylaxis, *ANTIVIRAL agents, *COVID-19, *EXPERIENTIAL learning
Abstract

The article focuses on David R. Boulware's transition from cryptococcal research to leading rapid COVID-19 clinical trials, including hydroxychloroquine. It details challenges in trial design, public scrutiny, and navigating misinformation during the pandemic, emphasizing the importance of rigorous scientific inquiry in public health emergencies.

Published
2024
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29. GeneXpert MTB/Rif to Diagnose Tuberculous Meningitis: Perhaps the First Test but not the Last

Author

Bahr, Nathan C, Marais, Suzaan, Caws, Maxine, van Crevel, Reinout, Wilkinson, Robert J, Tyagi, Jaya S, Thwaites, Guy E, Boulware, David R, Aarnoutse, Rob, Van Crevel, Reinout, van Laarhoven, Aarjan, Dian, Sofiati, Cronan, Mark R, Tobin, David, Dooley, Kelly, Dunstan, Sarah, Feng, Guo-dong, Shi, Xiaodan, Wang, Ting, Figaji, Anthony, McIlleron, Helen, Meintjes, Graeme, Rohlwink, Ursula, Rizal, Ahmad, Ruslami, Rovina, Garg, Ravindra K, Gupta, Mudit, Gupta, Rakesh K, Gupta, Sneha, Savic, Rada, Heemskerk, Anna D, Nguyễn, Thương Thụy Thương, Nguyễn, Mai Thị Hoàng, Srinivasan, Vijay, Thwaites, Guy, Trần, Trâm Thị Bích, Trần, Thịnh Thi Vân, Trần, Anh Thi Ngọc, Võ, Trang Hồng Yêng, Wolbers, Marcel, Kalita, Jayantee, Misra, Usha K, Lai, Rachel, Marais, Ben J, Trinh, Mai Quỳnh, Nguyễn, Bằng Đức, Nguyễn, Yến Bích, Patel, Vinod, Pouplin, Thomas, Ramakrishnan, Lalita, Schoeman, Johan F, Solomons, Regan, Van Toorn, Ronald, Seddon, James, Shah, Javeed, and Visser, Douwe H

Subjects
Rare Diseases, Good Health and Well Being, DNA, Bacterial, Humans, Mycobacterium tuberculosis, Nucleic Acid Amplification Techniques, Tuberculosis, Meningeal, Tuberculous Meningitis International Research Consortium, diagnosis, guideline, meningitis, perspective, tuberculous, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

Tuberculous meningitis (TBM) is the most severe form of tuberculous with substantial mortality. In May 2015, 54 researchers from 10 countries met in Da Lat, Vietnam, to discuss advances in TBM. Among the attendees were researchers involved in pivotal studies on the use of Xpert MTB/Rif for TBM diagnosis. Attendees discussed the 2014 World Health Organization strong recommendation favoring the use of Xpert "in preference to conventional microscopy and culture as the initial diagnostic test for cerebrospinal fluid (CSF) if the sample volume is low or if additional specimens cannot be obtained to make a quick diagnosis." Attendees were concerned that the limitations of Xpert testing for TBM are not emphasized. Clear guidance is needed for the investigational pathway for TBM, including recommendations on the diagnostic package of investigations, which does not stop with Xpert testing. Second, emphasis on the large CSF volumes (ideally 8-10 mL) needed for Xpert testing is required. Guidelines should also emphasize that TBM is a medical emergency and early treatment reduces mortality.

Published
2016

30. Divergent neuroimmune signatures in the cerebrospinal fluid predict differential gender-specific survival among patients with HIV-associated cryptococcal meningitis

Author

Okurut, Samuel, primary, Boulware, David R., additional, Okafor, Elizabeth, additional, Rhein, Joshua, additional, Kajumbula, Henry, additional, Bagaya, Bernard S., additional, Bwanga, Freddie, additional, Olobo, Joseph O., additional, Manabe, Yukari C., additional, Meya, David B., additional, and Janoff, Edward N., additional

Published
2023
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31. Utility of Cerebrospinal Fluid Protein Levels as a Potential Predictive Biomarker of Disease Severity in HIV-Associated Cryptococcal Meningitis

Author

Kasibante, John, primary, Irfanullah, Eesha, additional, Wele, Abduljewad, additional, Okafor, Elizabeth, additional, Ssebambulidde, Kenneth, additional, Okurut, Samuel, additional, Kagimu, Enock, additional, Gakuru, Jane, additional, Rutakingirwa, Morris K., additional, Mugabi, Timothy, additional, Nuwagira, Edwin, additional, Jjunju, Samuel, additional, Mpoza, Edward, additional, Tugume, Lillian, additional, Nsangi, Laura, additional, Musibire, Abdu K, additional, Muzoora, Conrad, additional, Rhein, Joshua, additional, Meya, David B., additional, Boulware, David R., additional, and Abassi, Mahsa, additional

Published
2023
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33. 1506. Prevalence of Histoplasma Antigenuria among an outpatient Advanced HIV cohort in Kampala,Uganda

Author

Sekar, Preethiya, primary, Nalintya, Elizabeth, additional, Kwizera, Richard, additional, Mukashyaka, Claudine, additional, Niyonzima, Godfrey, additional, Namakula, Olive Loryndah, additional, Nerima, Patricia, additional, Fieberg, Ann, additional, Dai, Biyue, additional, Bahr, Nathan C, additional, Ellis, Jayne, additional, Meya, David, additional, Boulware, David R, additional, and Rajasingham, Radha, additional

Published
2023
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34. 1490. Predictors of Early Mortality in HIV-associated Tuberculous Meningitis

Author

Kagimu, Enock, primary, Bangdiwala, Ananta, additional, Kasibante, John, additional, Kabahubya, Mable, additional, Gakuru, Jane, additional, Timothy, Mugabi, additional, Namombwe, Suzan, additional, Kimuda, Sarah, additional, Kasozi, Derrick, additional, Rutakingirwa, Morris K, additional, Ssebambulidde, Kenneth, additional, Tugume, Lillian, additional, Nuwagira, Edwin, additional, Okurut, Samuel, additional, Nsangi, Laura, additional, Atukunda, Mucunguzi, additional, Ellis, Jayne P, additional, Williams, Darlisha A, additional, Musubire, Abdu Kisekka, additional, Boulware, David R, additional, Meya, David, additional, Bahr, Nathan C, additional, and Cresswell, Fiona V, additional

Published
2023
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36. Finger-Prick Whole Blood Cryptococcal Antigen Lateral Flow Assay for the Diagnosis of Cryptococcosis in HIV-Negative Patients: A Case Series Study in Two Tertiary Centers in São Paulo, Brazil

Author

Vidal, José E., primary, Oliveira, Fernanda Gurgel, additional, Vieira, Marcela, additional, Pereira, Luisa, additional, Lucas Junior, Rodovaldo M., additional, Guedes, Bruno Fukelman, additional, Magri, Marcello Chaves, additional, and Boulware, David R., additional

Published
2023
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38. 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

Author

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.

Published
2020
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40. Cryptococcosis and HIV

Author

Rajasingham, Radha, Boulware, David R., Hope, Thomas J., editor, Richman, Douglas D., editor, and Stevenson, Mario, editor

Published
2018
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41. Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomised, placebo-controlled, double-blind phase 3 trial

Author

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

Published
2019
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42. Leave no one behind: response to new evidence and guidelines for the management of cryptococcal meningitis in low-income and middle-income countries

Author

Loyse, Angela, Burry, Jessica, Cohn, Jennifer, Ford, Nathan, Chiller, Tom, Ribeiro, Isabela, Koulla-Shiro, Sinata, Mghamba, Janneth, Ramadhani, Angela, Nyirenda, Rose, Aliyu, Sani H, Wilson, Douglas, Le, Thuy, Oladele, Rita, Lesikari, Sokoine, Muzoora, Conrad, Kalata, Newton, Temfack, Elvis, Mapoure, Yacouba, Sini, Victor, Chanda, Duncan, Shimwela, Meshack, Lakhi, Shabir, Ngoma, Jonathon, Gondwe-Chunda, Lilian, Perfect, Chase, Shroufi, Amir, Andrieux-Meyer, Isabelle, Chan, Adrienne, Schutz, Charlotte, Hosseinipour, Mina, Van der Horst, Charles, Klausner, Jeffrey D, Boulware, David R, Heyderman, Robert, Lalloo, David, Day, Jeremy, Jarvis, Joseph N, Rodrigues, Marcio, Jaffar, Shabbar, Denning, David, Migone, Chantal, Doherty, Megan, Lortholary, Olivier, Dromer, Françoise, Stack, Muirgen, Molloy, Síle F, Bicanic, Tihana, van Oosterhout, Joep, Mwaba, Peter, Kanyama, Cecilia, Kouanfack, Charles, Mfinanga, Sayoki, Govender, Nelesh, and Harrison, Thomas S

Published
2019
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44. Inhaled Fluticasone Furoate for Outpatient Treatment of Covid-19

Author

Boulware, David R., primary, Lindsell, Christopher J., additional, Stewart, Thomas G., additional, Hernandez, Adrian F., additional, Collins, Sean, additional, McCarthy, Matthew William, additional, Jayaweera, Dushyantha, additional, Gentile, Nina, additional, Castro, Mario, additional, Sulkowski, Mark, additional, McTigue, Kathleen, additional, Felker, G. Michael, additional, Ginde, Adit A., additional, Dunsmore, Sarah E., additional, Adam, Stacey J., additional, DeLong, Allison, additional, Hanna, George, additional, Remaly, April, additional, Thicklin, Florence, additional, Wilder, Rhonda, additional, Wilson, Sybil, additional, Shenkman, Elizabeth, additional, and Naggie, Susanna, additional

Published
2023
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45. 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

Author

Ellis, Jayne, primary, Bangdiwala, Ananta S, additional, Skipper, Caleb P, additional, Tugume, Lillian, additional, Nsangi, Laura, additional, Matovu, John, additional, Pastick, Katelyn A, additional, Ssebambulidde, Kenneth, additional, Morawski, Bozena M, additional, Musubire, Abdu K, additional, Schleiss, Mark R, additional, Moore, David A J, additional, Jarvis, Joseph N, additional, Boulware, David R, additional, Meya, David B, additional, and Castelnuovo, Barbara, additional

Published
2023
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46. Oral Lipid Nanocrystal Amphotericin B for Cryptococcal Meningitis: A Randomized Clinical Trial

Author

Boulware, David R, primary, Atukunda, Mucunguzi, additional, Kagimu, Enock, additional, Musubire, Abdu K, additional, Akampurira, Andrew, additional, Tugume, Lillian, additional, Ssebambulidde, Kenneth, additional, Kasibante, John, additional, Nsangi, Laura, additional, Mugabi, Timothy, additional, Gakuru, Jane, additional, Kimuda, Sarah, additional, Kasozi, Derrick, additional, Namombwe, Suzan, additional, Turyasingura, Isaac, additional, Rutakingirwa, Morris K, additional, Mpoza, Edward, additional, Kigozi, Enos, additional, Muzoora, Conrad, additional, Ellis, Jayne, additional, Skipper, Caleb P, additional, Matkovits, Theresa, additional, Williamson, Peter R, additional, Williams, Darlisha A, additional, Fieberg, Ann, additional, Hullsiek, Kathy H, additional, Abassi, Mahsa, additional, Dai, Biyue, additional, and Meya, David B, additional

Published
2023
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48. The STOP COVID 2 Study: Fluvoxamine vs Placebo for Outpatients With Symptomatic COVID-19, a Fully Remote Randomized Controlled Trial

Author

Reiersen, Angela M, primary, Mattar, Caline, additional, Bender Ignacio, Rachel A, additional, Boulware, David R, additional, Lee, Todd C, additional, Hess, Rachel, additional, Lankowski, Alexander J, additional, McDonald, Emily G, additional, Miller, J Philip, additional, Powderly, William G, additional, Pullen, Matthew F, additional, Rado, Jeffrey T, additional, Rich, Michael W, additional, Schiffer, Joshua T, additional, Schweiger, Julie, additional, Spivak, Adam M, additional, Stevens, Angela, additional, Vigod, Simone N, additional, Agarwal, Payal, additional, Yang, Lei, additional, Yingling, Michael, additional, Gettinger, Torie R, additional, Zorumski, Charles F, additional, and Lenze, Eric J, additional

Published
2023
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