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1. 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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2. 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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4. 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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5. Role of cytokines in predicting one-year mortality in non-traumatic spinal cord injury (NTCSI) patients in Uganda

Author

Musubire, Abdu Kisekka, primary, Valkiers, Sebastiaan, additional, Ssebambulidde, Kenneth, additional, Kwizera, Richard, additional, David, Boulware, additional, Bohjanen, Paul, additional, Kasibante, John, additional, Skipper, Caleb, additional, Meya, David, additional, Cras, Patrick, additional, and Willekens, Barbara, additional

Published
2023
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7. 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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8. 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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10. 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

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

Published
2022
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11. 869. Oral Encochleated Amphotericin B for Cryptococcal Meningitis: a Phase II Randomized Trial

Author

Atukunda, Mucunguzi, primary, Kagimu, Enock, additional, Rutakingirwa, Morris K, additional, Tugume, Lillian, additional, Nsangi, Laura, additional, Musubire, Abdu, additional, Gakuru, Jane, additional, Mugabi, Timothy, additional, Akampurira, Andrew, additional, Ssebambulidde, Kenneth, additional, Kasibante, John, additional, Ellis, Jayne, additional, Mpoza, Edward, additional, Williams, Darlisha A, additional, Fieberg, Ann M, additional, Skipper, Caleb, additional, Abassi, Mahsa, additional, Hullsiek, Kathy Huppler, additional, Meya, David, additional, and Boulware, David R, additional

Published
2022
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12. Diagnostic and Prognostic Value of Cerebrospinal Fluid Lactate and Glucose in HIV-Associated Tuberculosis Meningitis

Author

Nuwagira, Edwin, primary, Huppler Hullsiek, Kathy, additional, Jjunju, Samuel, additional, Rutakingirwa, Morris, additional, Kasibante, John, additional, Tadeo, Kiiza Kandole, additional, Kagimu, Enock, additional, Tugume, Lillian, additional, Ssebambulidde, Kenneth, additional, Musubire, Abdu K., additional, Bangdiwala, Ananta, additional, Muzoora, Conrad, additional, Meya, David B., additional, Boulware, David R., additional, Bahr, Nathan C., additional, and Creswell, Fiona V., additional

Published
2022
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13. Therapeutic Lumbar Punctures in Human Immunodeficiency Virus–Associated Cryptococcal Meningitis: Should Opening Pressure Direct Management?

Author

Kagimu, Enock, primary, Engen, Nicole, additional, Ssebambulidde, Kenneth, additional, Kasibante, John, additional, Kiiza, Tadeo K, additional, Mpoza, Edward, additional, Tugume, Lillian, additional, Nuwagira, Edwin, additional, Nsangi, Laura, additional, Williams, Darlisha A, additional, Hullsiek, Kathy Huppler, additional, Boulware, David R, additional, Meya, David B, additional, Rhein, Joshua, additional, Abassi, Mahsa, additional, and Musubire, Abdu K, additional

Published
2022
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14. Association of Hyponatremia on Mortality in Cryptococcal Meningitis: A Prospective Cohort

Author

Tugume, Lillian, Fieberg, Ann, Ssebambulidde, Kenneth, Nuwagira, Edwin, Williams, Darlisha A, Mpoza, Edward, Rutakingirwa, Morris K, Kagimu, Enoch, Kasibante, John, Nsangi, Laura, Jjunju, Samuel, Musubire, Abdu K, Muzoora, Conrad, Lawrence, David S, Rhein, Joshua, Meya, David B, Hullsiek, Kathy Huppler, Boulware, David R, Abassi, Mahsa, and Adjunctive Sertraline for HIV-Associated Cryptococcal Meningitis

Abstract

BACKGROUND: Sodium abnormalities are frequent in central nervous system infections and may be caused by cerebral salt wasting, syndrome of inappropriate antidiuretic hormone secretion, or medication adverse events. In cryptococcal meningitis (CM), the prevalence of baseline hyponatremia and whether hyponatremia adversely impacts survival is unknown. METHODS: We conducted a secondary analysis of data from 2 randomized trials of human immunodeficiency virus-infected adult Ugandans with CM. We grouped serum sodium into 3 categories

Published
2022

15. Outpatient Cryptococcal Antigen Screening Is Associated With Favorable Baseline Characteristics and Improved Survival in Persons With Cryptococcal Meningitis in Uganda

Author

Levin, Anna E, primary, Bangdiwala, Ananta S, additional, Nalintya, Elizabeth, additional, Kagimu, Enock, additional, Kasibante, John, additional, Rutakingirwa, Morris K, additional, Mpoza, Edward, additional, Jjunju, Samuel, additional, Nuwagira, Edwin, additional, Naluyima, Rose, additional, Kirumira, Paul, additional, Hou, Cody, additional, Ssebambulidde, Kenneth, additional, Musubire, Abdu K, additional, Williams, Darlisha A, additional, Abassi, Mahsa, additional, Muzoora, Conrad, additional, Hullsiek, Katherine H, additional, Rajasingham, Radha, additional, Meya, David B, additional, Boulware, David R, additional, and Skipper, Caleb P, additional

Published
2022
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16. Single-Dose Liposomal Amphotericin B Treatment for Cryptococcal Meningitis

Author

Jarvis, Joseph N, Lawrence, David S, Meya, David B, Kagimu, Enock, Kasibante, John, Mpoza, Edward, Rutakingirwa, Morris K, Ssebambulidde, Kenneth, Tugume, Lillian, Rhein, Joshua, Boulware, David R, Mwandumba, Henry C, Moyo, Melanie, Mzinganjira, Henry, Kanyama, Cecilia, Hosseinipour, Mina C, Chawinga, Chimwemwe, Meintjes, Graeme, Schutz, Charlotte, Comins, Kyla, Singh, Achita, Muzoora, Conrad, Jjunju, Samuel, Nuwagira, Edwin, Mosepele, Mosepele, Leeme, Tshepo, Siamisang, Keatlaretse, Ndhlovu, Chiratidzo E, Hlupeni, Admire, Mutata, Constantine, van Widenfelt, Erik, Chen, Tao, Wang, Duolao, Hope, William, Boyer-Chammard, Timothée, Loyse, Angela, Molloy, Síle F, Youssouf, Nabila, Lortholary, Olivier, Lalloo, David G, Jaffar, Shabbar, Harrison, Thomas S, Ambition Study Group, London School of Hygiene and Tropical Medicine (LSHTM), Bostwana Harvard AIDS Institute Partneship Gaborone, National Center for Atmospheric Research [Boulder] (NCAR), University of North Carolina Project-Malawi (UNC Project), University of North Carolina [Chapel Hill] (UNC), University of North Carolina System (UNC), University of Cape Town, Mycologie moléculaire - Molecular Mycology, Institut Pasteur [Paris]-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPC), Centre National de Référence Mycoses Invasives et Antifongiques - National Reference Center Invasive Mycoses & Antifungals (CNRMA), Institut Pasteur [Paris]-Université Paris Cité (UPC), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Supported by a grant (TRIA2015-1092) through the European and Developing Countries Clinical Trials Partnership, with assistance from the Swedish International Development Cooperation Agency, as well as by funding from the U.K. Department of Health and Social Care, the U.K. Foreign Commonwealth and Development Office, the U.K. Medical Research Council, and Wellcome Trust, through the Joint Global Health Trials scheme (MR/P006922/1). Funding was also provided by the National Institute for Health Research (NIHR) through a Global Health Research Professorship (RP-2017-08-ST2-012, to Dr. Jarvis) with aid from the U.K. government to support global health research. Dr. Meintjes was supported by grants (098316, 214321/Z/18/Z, and 203135/Z/16/Z) from the Wellcome Trust and a grant (64787) from the South African Research Chairs Initiative of the Department of Science and Technology and the National Research Foundation of South Africa. Diagnostic testing in Uganda was supported by a grant (R01NS086312) from the National Institute of Neurological Disorders and Stroke. Dr. Rhein was supported by a grant (K01 TW010268) from the Fogarty International Center. Liposomal amphotericin B (AmBisome) was donated by Gilead Sciences., We thank the trial participants and their families and caregivers, as well as all the clinical, laboratory, and administrative staff at all the sites who were not directly involved in the trial, Andrew Nunn, Sayoki Mfinanga, Robert Peck, and William Powderly for serving on the data and safety monitoring committee, and John Perfect, Andrew Kambugu, Saidi Kapigi, and Douglas Wilson for serving on the trial steering committee. We dedicate the trial to the memory of Siphokazi Hlungulu, who worked as a research nurse and study coordinator for the Cape Town Ambition site for the duration of the trial and died before seeing the results published., Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), and Institut Pasteur [Paris] (IP)-Université Paris Cité (UPCité)

Subjects
wl_200, qv_350, General Medicine, [SDV.MP.MYC]Life Sciences [q-bio]/Microbiology and Parasitology/Mycology, wc_245
Abstract

BackgroundCryptococcal meningitis is a leading cause of human immunodeficiency virus (HIV)-related death in sub-Saharan Africa. Whether a treatment regimen that includes a single high dose of liposomal amphotericin B would be efficacious is not known.MethodsIn this phase 3 randomized, controlled, noninferiority trial conducted in five African countries, we assigned HIV-positive adults with cryptococcal meningitis in a 1:1 ratio to receive either a single high dose of liposomal amphotericin B (10 mg per kilogram of body weight) on day 1 plus 14 days of flucytosine (100 mg per kilogram per day) and fluconazole (1200 mg per day) or the current World Health Organization-recommended treatment, which includes amphotericin B deoxycholate (1 mg per kilogram per day) plus flucytosine (100 mg per kilogram per day) for 7 days, followed by fluconazole (1200 mg per day) for 7 days (control). The primary end point was death from any cause at 10 weeks; the trial was powered to show noninferiority at a 10-percentage-point margin.ResultsA total of 844 participants underwent randomization; 814 were included in the intention-to-treat population. At 10 weeks, deaths were reported in 101 participants (24.8%; 95% confidence interval [CI], 20.7 to 29.3) in the liposomal amphotericin B group and 117 (28.7%; 95% CI, 24.4 to 33.4) in the control group (difference, -3.9 percentage points); the upper boundary of the one-sided 95% confidence interval was 1.2 percentage points (within the noninferiority margin; P10 colony-forming units (CFU) per milliliter per day in the liposomal amphotericin B group and -0.42 log10 CFU per milliliter per day in the control group. Fewer participants had grade 3 or 4 adverse events in the liposomal amphotericin B group than in the control group (50.0% vs. 62.3%).ConclusionsSingle-dose liposomal amphotericin B combined with flucytosine and fluconazole was noninferior to the WHO-recommended treatment for HIV-associated cryptococcal meningitis and was associated with fewer adverse events. (Funded by the European and Developing Countries Clinical Trials Partnership and others; Ambition ISRCTN number, ISRCTN72509687.).

Published
2022

17. Outpatient Cryptococcal Antigen Screening Is Associated With Favorable Baseline Characteristics and Improved Survival in Persons With Cryptococcal Meningitis in Uganda.

Author

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

Subjects
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]

Published
2023
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19. 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.

Author

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

Subjects
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]

Published
2021
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22. Utility of Cerebrospinal Fluid Protein Levels as a Potential Predictive Biomarker of Disease Severity in HIV-Associated Cryptococcal Meningitis.

Author

Kasibante J, Irfanullah E, Wele A, Okafor E, Ssebambulidde K, Okurut S, Kagimu E, Gakuru J, Rutakingirwa MK, Mugabi T, Nuwagira E, Jjunju S, Mpoza E, Tugume L, Nsangi L, Musibire AK, Muzoora C, Rhein J, Meya DB, Boulware DR, and Abassi M

Abstract

Background: Cerebrospinal fluid (CSF) protein levels exhibit high variability in HIV-associated cryptococcal meningitis from being normal to markedly elevated. However, the clinical implications of CSF protein levels in cryptococcal meningitis remain unclear., Methods: We analysed data from 890 adults with HIV-associated cryptococcal meningitis randomized into two clinical trials in Uganda between 2015 and 2021. CSF protein was grouped into ≥100 mg/dL (n=249) and <100 mg/dL (n=641). We described baseline clinical variables and mortality by CSF protein levels., Results: Approximately one-third of individuals had a baseline CSF protein ≥100 mg/dL. Those with CSF protein ≥100 mg/dL were more likely to present with Glasgow coma scale scores <15 (P<0.01), self-reported seizures at baseline (P=0.02), higher CD4 T-cells (p<0.001), and higher CSF white cells (p<0.001). Moreover, those with a baseline CSF protein ≥100 mg/dL also had a lower baseline CSF fungal burden (p<0.001) and a higher percentage of sterile CSF cultures at day 14 (p=0.02). Individuals with CSF protein ≥100 mg/dL demonstrated a more pronounced immune response consisting of upregulation of immune effector molecules pro-inflammatory cytokines, type-1 T-helper cell cytokines, type-3 chemokines, and immune-exhaustion marker (p<0.05). 18-week mortality risk in individuals with a CSF protein <100 mg/dL was 34% higher, (unadjusted Hazard Ratio 1.34; 95% CI, 1.05 to 1.70; p=0.02) than those with ≥100 mg/dL., Conclusion: In cryptococcal meningitis, individuals with CSF protein ≥100 mg/dL more frequently presented with seizures, altered mental status, immune activation, and favourable fungal outcomes. Baseline CSF protein levels may serve as a surrogate marker of immune activation and prognosis., Competing Interests: Potential conflicts of interest. All authors: no reported conflicts of interest.

Published
2023
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23. Association of Hyponatremia on Mortality in Cryptococcal Meningitis: A Prospective Cohort.

Author

Tugume L, Fieberg A, Ssebambulidde K, Nuwagira E, Williams DA, Mpoza E, Rutakingirwa MK, Kagimu E, Kasibante J, Nsangi L, Jjunju S, Musubire AK, Muzoora C, Lawrence DS, Rhein J, Meya DB, Hullsiek KH, Boulware DR, and Abassi M

Abstract

Background: Sodium abnormalities are frequent in central nervous system infections and may be caused by cerebral salt wasting, syndrome of inappropriate antidiuretic hormone secretion, or medication adverse events. In cryptococcal meningitis (CM), the prevalence of baseline hyponatremia and whether hyponatremia adversely impacts survival is unknown., Methods: We conducted a secondary analysis of data from 2 randomized trials of human immunodeficiency virus-infected adult Ugandans with CM. We grouped serum sodium into 3 categories: <125, 125-129, and 130-145 mmol/L. We assessed whether baseline sodium abnormalities were associated with clinical characteristics and survival., Results: Of 816 participants with CM, 741 (91%) had a baseline sodium measurement available: 121 (16%) had grade 3-4 hyponatremia (<125 mmol/L), 194 (26%) had grade 2 hyponatremia (125-129 mmol/L), and 426 (57%) had a baseline sodium of 130-145 mmol/L. Hyponatremia (<125 mmol/L) was associated with higher initial cerebrospinal fluid (CSF) quantitative culture burden ( P  < .001), higher initial CSF opening pressure ( P  < .01), lower baseline Glasgow Coma Scale score ( P  < .01), and a higher percentage of baseline seizures ( P  = .03). Serum sodium <125 mmol/L was associated with increased 2-week mortality in unadjusted and adjusted survival analyses (adjusted hazard ratio, 1.87 [95% confidence interval, 1.26-2.79]; P  < .01) compared to those with sodium 130-145 mmol/L., Conclusions: Hyponatremia is common in CM and is associated with excess mortality. A standardized management approach to correctly diagnose and correct hyponatremia in CM needs to be developed and tested., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Published
2022
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24. Single-Dose Liposomal Amphotericin B Treatment for Cryptococcal Meningitis.

Author

Jarvis JN, Lawrence DS, Meya DB, Kagimu E, Kasibante J, Mpoza E, Rutakingirwa MK, Ssebambulidde K, Tugume L, Rhein J, Boulware DR, Mwandumba HC, Moyo M, Mzinganjira H, Kanyama C, Hosseinipour MC, Chawinga C, Meintjes G, Schutz C, Comins K, Singh A, Muzoora C, Jjunju S, Nuwagira E, Mosepele M, Leeme T, Siamisang K, Ndhlovu CE, Hlupeni A, Mutata C, van Widenfelt E, Chen T, Wang D, Hope W, Boyer-Chammard T, Loyse A, Molloy SF, Youssouf N, Lortholary O, Lalloo DG, Jaffar S, and Harrison TS

Subjects
AIDS-Related Opportunistic Infections mortality, Administration, Oral, Africa South of the Sahara, Amphotericin B adverse effects, Antifungal Agents adverse effects, Drug Administration Schedule, Drug Therapy, Combination, Fluconazole adverse effects, Flucytosine adverse effects, HIV Infections complications, Meningitis, Cryptococcal mortality, AIDS-Related Opportunistic Infections drug therapy, Amphotericin B administration & dosage, Antifungal Agents administration & dosage, Fluconazole administration & dosage, Flucytosine administration & dosage, Meningitis, Cryptococcal drug therapy
Abstract

Background: Cryptococcal meningitis is a leading cause of human immunodeficiency virus (HIV)-related death in sub-Saharan Africa. Whether a treatment regimen that includes a single high dose of liposomal amphotericin B would be efficacious is not known., Methods: In this phase 3 randomized, controlled, noninferiority trial conducted in five African countries, we assigned HIV-positive adults with cryptococcal meningitis in a 1:1 ratio to receive either a single high dose of liposomal amphotericin B (10 mg per kilogram of body weight) on day 1 plus 14 days of flucytosine (100 mg per kilogram per day) and fluconazole (1200 mg per day) or the current World Health Organization-recommended treatment, which includes amphotericin B deoxycholate (1 mg per kilogram per day) plus flucytosine (100 mg per kilogram per day) for 7 days, followed by fluconazole (1200 mg per day) for 7 days (control). The primary end point was death from any cause at 10 weeks; the trial was powered to show noninferiority at a 10-percentage-point margin., Results: A total of 844 participants underwent randomization; 814 were included in the intention-to-treat population. At 10 weeks, deaths were reported in 101 participants (24.8%; 95% confidence interval [CI], 20.7 to 29.3) in the liposomal amphotericin B group and 117 (28.7%; 95% CI, 24.4 to 33.4) in the control group (difference, -3.9 percentage points); the upper boundary of the one-sided 95% confidence interval was 1.2 percentage points (within the noninferiority margin; P<0.001 for noninferiority). Fungal clearance from cerebrospinal fluid was -0.40 log 10 colony-forming units (CFU) per milliliter per day in the liposomal amphotericin B group and -0.42 log 10 CFU per milliliter per day in the control group. Fewer participants had grade 3 or 4 adverse events in the liposomal amphotericin B group than in the control group (50.0% vs. 62.3%)., Conclusions: Single-dose liposomal amphotericin B combined with flucytosine and fluconazole was noninferior to the WHO-recommended treatment for HIV-associated cryptococcal meningitis and was associated with fewer adverse events. (Funded by the European and Developing Countries Clinical Trials Partnership and others; Ambition ISRCTN number, ISRCTN72509687.)., (Copyright © 2022 Massachusetts Medical Society.)

Published
2022
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