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1. Development of tuberculosis treatment decision algorithms in children below 5 years hospitalised with severe acute malnutrition in Zambia and Uganda: a prospective diagnostic cohort study

Author

Marcy, Olivier, Serre, Angeline, Badrichani, Anne, Razafimanantsoa, Manoa, Poublan, Julien, Vessière, Aurélia, Roucher, Clémentine, Occelli, Estelle, Beuscart, Aurélie, Charpin, Aurélie, Habiyambere, Gemma, Mesnier, Salomé, Balestre, Eric, Koskas, Nicolas, D'Elbée, Marc, Font, Hélène, Ton Nu Nguyet, Minh Huyen, Bonnet, Maryline, Lounnas, Manon, Espérou, Hélène, Couffin-Cadiergues, Sandrine, Kuppers, Alexis, Hamze, Benjamin, Wobudeya, Eric, Businge, Gerald Bright, Namulinda, Faith, Sserunjogi, Robert, Nassozi, Rashidah, Barungi, Charlotte, Hellen, Aanyu, Doreen, Muwonge, Kagoya, Eva, Aciparu, Serene, Sophia, Chemutai, Ntambi, Samuel, Wasswa, Amir, Nangozi, Juliet, Chabala, Chishala, Mulenga, Veronica, Shankalala, Perfect, Hambulo, Chimuka, Kapotwe, Vincent, Ngambi, Marjory, Kasakwa, Kunda, Kanyama, Mirriam, Chirwa, Uzima, Chifunda, Kapula, Mundundu, Gae, Zulu, Susan, Nawakwi, Grace, Siasulingana, Teddy, Himwaze, Diana Attan, Chilonga, Jessy, Chimbini, Maria, Chilanga, Mutinta, Chola, Daniel, Mwango, Eustace, Nduna, Bwendo, Inambao, Muleya, Pumbwe, Mwamba, Mwambazi, Mwate, Halende, Barbara, Mumba, Wyclef, Mankunshe, Endreen, Silavwe, Maureen, Chakopo, Moses, Moono, Roy, Chungu, Chalilwe, Zimba, Kevin, Kapasa, Monica, Zyambo, Khozya, Babirekere, Esther, Businge, Gerald, Kapula, Chifunda, and Graham, Stephen

Published
2024
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2. Inadequate Lopinavir Concentrations With Modified 8-Hourly Lopinavir/Ritonavir 4: 1 Dosing During Rifampicin-based Tuberculosis Treatment in Children Living With HIV

Author

Chabala, Chishala, Turkova, Anna, Kapasa, Monica, LeBeau, Kristen, Tembo, Chimuka H., Zimba, Kevin, Weisner, Lubbe, Zyambo, Khozya, Choo, Louise, Chungu, Chalilwe, Lungu, Joyce, Mulenga, Veronica, Crook, Angela, Gibb, Diana, McIlleron, Helen, Gibb, Diana M., Turkova, Anna, Crook, Angela M., Choo, Louise, Wills, Genevieve, Thomason, Margaret J., Teera, Jaqueline, Owen- Powell, Ellen, LeBeau, Kristen, Baptiste, David, McGowan, Charlotte, Spyer, Moira, Chabala, Chishala, Mulenga, Veronica, Lungu, Joyce, Kapasa, Monica, Zimba, Kevin, Zyambo, Khozya, Chungu, Chalilwe, Tembo, Chimuka, Kunda, Sharon, Shingalili, Ellen, Zulu, Semy, Chipoya, Terence, Mwanakalanga, Habulembe, Chambela, Elias, Hankombo, Jessy M., Kalumbi, Mox Malama, Chola, Daniel, Malama, Stephen, Wobudeya, Eric, Musoke, Philippa, Baldwin, Mboizi Robert, Nansamba, Winnie, Ssenyonga, Mark, Ssengooba, Willy, Businge, Gerald, Hesseling, Anneke C., Palmer, Megan, van der Zalm, Marieke M., Workman, Jessica, Demers, Anne-Marie, Schaaf, Simon, Gie, Robert, Walters, Elisabetta, Zimri, Warren, Hoddinott, Graeme, Deventer, Anneen van, Goussard, Pierre, Morrison, Julie, Mave, Vidya, (PI), Kinikar, Aarti Avinash, Raichur, Priyanka, Nijampurkar, Aparna, Khan, Sameer, Hissar, Syed, Joseph, Bency, Bhavani, Perumal Kannabiran, Prathiksha, G, Baskaran, Dhanaraj, Gomathi, NS, Mythily, V, Kumar, Hemanth, Chelvi, Silambu, Sekar, L, Hanna, Luke, Ramesh, K, Latha, Hema, Bharathi, S, Banu, Parveen, Xavier, Dino, Kumar, Manjith, Guru, K, Kumar, Sasi, Kesavan, A, Gunasundari, A, Mangalambal, G, Nagarajan, Valarmathi, Shankar, Shakeela, Selvi, R, Vaishnavi, S, Yadav, Krishna, Supriya, R, Giranab, Hema, Seetha, A, Mary, Stella, Gopika, S, Rohini, S, Revathy, M, Balaji, Sarath, Elilarasi, S, Ganesh, J, Aravind, MA, Mulambo, Sylvia, Mwanyungwi, Hope, Tapse, Dharati, Sane, Manasi, Abdullah, Amina, Nakalanzi, Sarah, Williams, Cynthia Mukisa, McIlleron, Helen, Aarnoutse, Rob, Revill, Paul, Love-Koh, James, Walker, Simon, Mugyenyi, Peter, Darbyshire, Janet, Clayden, Polly, Donald, Peter, Singh, Varinder, Grzemska*, Malgosia, Swaminathan, Soumya, Verkuijl, *Replaced by Sabine, Peto, Tim, Mwinga, Alwyn, Fielding, Katherine, Graham, Stephen M., Welch, Steven B., Seddon, James A., Whittaker, Elizabeth, Anderson, Suzanne, and Grandjean, Louis

Published
2023
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5. Clinical Outcomes in Children With Human Immunodeficiency Virus Treated for Nonsevere Tuberculosis in the SHINE Trial.

Author

Chabala, Chishala, Wobudeya, Eric, Zalm, Marieke M van der, Kapasa, Monica, Raichur, Priyanka, Mboizi, Robert, Palmer, Megan, Kinikar, Aarti, Hissar, Syed, Mulenga, Veronica, Mave, Vidya, Musoke, Philippa, Hesseling, Anneke C, McIlleron, Helen, Gibb, Diana, Crook, Angela, Turkova, Anna, and Team, the SHINE Trial

Subjects
DRUG therapy for tuberculosis, TUBERCULOSIS mortality, HIV infection complications, ANEMIA, SECONDARY analysis, LEANNESS, RESEARCH funding, VIRAL load, MALNUTRITION, HIV-positive persons, HOSPITAL care, CD4 lymphocyte count, HEMOGLOBINS, HIV infections, TREATMENT effectiveness, DESCRIPTIVE statistics, ANTITUBERCULAR agents, ODDS ratio, ANTI-HIV agents, COMPARATIVE studies, DISEASE relapse, ADVERSE health care events, CONFIDENCE intervals, CHILDREN
Abstract

Background Children with human immunodeficiency virus (HIV, CWH) are at high risk of tuberculosis (TB) and face poor outcomes, despite antiretroviral therapy (ART). We evaluated outcomes in CWH and children not living with HIV treated for nonsevere TB in the SHINE trial. Methods SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH. Results Of 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P =.07) but more underweight (weight-for-age z score, −2.3; (3.3, −0.8 versus −1.0; −1.8, −0.2; P <.01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P <.01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241–1134), and CD4% was 16% (10–26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3–4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42). Conclusions We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration.  ISRCTN63579542. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Extended pre-exposure prophylaxis with lopinavir–ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial

Author

Van de Perre, Philippe, Nagot, Nicolas, Vallo, Roselyne, Marechal, Valerie, Peries, Marianne, Neveu, Dorine, Foulongne, Vincent, Segondy, Michel, Blanche, Stephane, Treluyer, Jean-Marc, Hirt, Deborah, Tumwine, James K, Ndeezi, Grace, Karamagi, Charles, Musoke, Philippa, Mugaba, Proscovia M, Kwagala, Mary, Murungi, Joan, Muweesi, Hawa Nabuuma, Ninsiima, Evelyn, Baryeija, Simon, Juma, Frederic, Kata, Caleb Bwengye, Katushabe, Stuart, Meda, Nicolas, Ouédraogo, Rasmata, Yé, Diarra, Somé, Eric, Traoré, Hugues A, Nadembega, Christelle, Konaté, Justin, Zongo, Arsène, Ouédraogo, Abass, Néboua, Désiré, Bélemviré, Aissatou, Bambara, Armel, Boncoungou, Justine, Zoungrana, Danielle, Nikodem, Cheryl, Hofmeyr, Justus, Harper, Kim, Jackson, Debra, Sanders, David, Singata, Mandisa, Aku, Amwe, Okegbe-Eze, Collins, Williams, Xoliswa, Mshweshwe, Nolundi, Henge, Vatiswa, Gomba, Fikiswa, Gundu, Tapiwa, Khondowe, Oswell, Kankasa, Chipepo, Mwiya, Mwiya, Lusaka, Mildred, Chizyuka, Mary, Phiri, Mary, Imakando, Billies, Musaku, Mwenechanya, Kapasa, Monica, Rutagwera, David, Clement, Gondwe, Mwaba, Hilton Mwila, Matoba, Japhet, Siuluta, Chafye, Chola, Katai, Mwamutanda, Patricia, Tylleskär, Thorkild, Sommerfelt, Halvor, Engebretsen, Ingunn, Klungsøyr, Jørn, van den Broeck, Jan, Blume, Jörn, Rekacewicz, Claire, Hofmeyr, G Justus, Traore, Hugues, Sunday, Amwe, Some, Eric, Neboua, Desire, Maréchal, Valérie, Engebretsen, Ingunn M S, Lombard, Carl, and Blanche, Stéphane

Published
2016
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10. Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial

Author

Chabala, Chishala, Turkova, Anna, Thomason, Margaret J., Wobudeya, Eric, Hissar, Syed, Mave, Vidya, van der Zalm, Marieke, Palmer, Megan, Kapasa, Monica, Bhavani, Perumal K., Balaji, Sarath, Raichur, Priyanka A., Demers, Anne-Marie, Hoddinott, Graeme, Owen-Powell, Ellen, Kinikar, Aarti, Musoke, Philippa, Mulenga, Veronica, Aarnoutse, Rob, McIlleron, Helen, Hesseling, Anneke, Crook, Angela M., Cotton, Mark, Gibb, Diana M., and on behalf of the SHINE trial team

Published
2018
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11. Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children

Author

Turkova, Anna, Wills, Genevieve H, Wobudeya, Eric, Chabala, Chishala, Palmer, Megan, Kinikar, Aarti, Hissar, Syed, Choo, Louise, Musoke, Philippa, Mulenga, Veronica, Mave, Vidya, Joseph, Bency, LeBeau, Kristen, Thomason, Margaret J, Mboizi, Robert B, Kapasa, Monica, van der Zalm, Marieke M, Raichur, Priyanka, Bhavani, Perumal K, McIlleron, Helen, Demers, Anne-Marie, Aarnoutse, Rob, Love-Koh, James, Seddon, James A, Welch, Steven B, Graham, Stephen M, Hesseling, Anneke C, Gibb, Diana M, Crook, Angela M, and SHINE Trial Team

Abstract

BACKGROUND: Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen. METHODS: We conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-susceptible, smear-negative tuberculosis in Uganda, Zambia, South Africa, and India. Children younger than 16 years of age were randomly assigned to 4 months (16 weeks) or 6 months (24 weeks) of standard first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the World Health Organization. The primary efficacy outcome was unfavorable status (composite of treatment failure [extension, change, or restart of treatment or tuberculosis recurrence], loss to follow-up during treatment, or death) by 72 weeks, with the exclusion of participants who did not complete 4 months of treatment (modified intention-to-treat population). A noninferiority margin of 6 percentage points was used. The primary safety outcome was an adverse event of grade 3 or higher during treatment and up to 30 days after treatment. RESULTS: From July 2016 through July 2018, a total of 1204 children underwent randomization (602 in each group). The median age of the participants was 3.5 years (range, 2 months to 15 years), 52% were male, 11% had human immunodeficiency virus infection, and 14% had bacteriologically confirmed tuberculosis. Retention by 72 weeks was 95%, and adherence to the assigned treatment was 94%. A total of 16 participants (3%) in the 4-month group had a primary-outcome event, as compared with 18 (3%) in the 6-month group (adjusted difference, -0.4 percentage points; 95% confidence interval, -2.2 to 1.5). The noninferiority of 4 months of treatment was consistent across the intention-to-treat, per-protocol, and key secondary analyses, including when the analysis was restricted to the 958 participants (80%) independently adjudicated to have tuberculosis at baseline. A total of 95 participants (8%) had an adverse event of grade 3 or higher, including 15 adverse drug reactions (11 hepatic events, all but 2 of which occurred within the first 8 weeks, when the treatments were the same in the two groups). CONCLUSIONS: Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis. (Funded by the U.K. Medical Research Council and others; SHINE ISRCTN number, ISRCTN63579542.).

Published
2022

12. Pharmacokinetics of First-Line Drugs in Children With Tuberculosis, Using World Health Organization–Recommended Weight Band Doses and Formulations

Author

Chabala, Chishala, primary, Turkova, Anna, additional, Hesseling, Anneke C, additional, Zimba, Kevin M, additional, van der Zalm, Marieke, additional, Kapasa, Monica, additional, Palmer, Megan, additional, Chirehwa, Maxwell, additional, Wiesner, Lubbe, additional, Wobudeya, Eric, additional, Kinikar, Aarti, additional, Mave, Vidya, additional, Hissar, Syed, additional, Choo, Louise, additional, LeBeau, Kristen, additional, Mulenga, Veronica, additional, Aarnoutse, Robb, additional, Gibb, Diana, additional, and McIlleron, Helen, additional

Published
2021
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13. Pharmacokinetics of First-Line Drugs in Children With Tuberculosis, Using World Health Organization–Recommended Weight Band Doses and Formulations.

Author

Chabala, Chishala, Turkova, Anna, Hesseling, Anneke C, Zimba, Kevin M, van der Zalm, Marieke, Kapasa, Monica, Palmer, Megan, Chirehwa, Maxwell, Wiesner, Lubbe, Wobudeya, Eric, Kinikar, Aarti, Mave, Vidya, Hissar, Syed, Choo, Louise, LeBeau, Kristen, Mulenga, Veronica, Aarnoutse, Robb, Gibb, Diana, and McIlleron, Helen

Subjects
DRUG therapy for tuberculosis, ETHAMBUTOL, PYRAZINAMIDE, ISONIAZID, RANDOMIZED controlled trials, ANTITUBERCULAR agents, DESCRIPTIVE statistics, PHARMACEUTICAL chemistry, RIFAMPIN, STATISTICAL sampling, CHILDREN
Abstract

Background Dispersible pediatric fixed-dose combination (FDC) tablets delivering higher doses of first-line antituberculosis drugs in World Health Organization–recommended weight bands were introduced in 2015. We report the first pharmacokinetic data for these FDC tablets in Zambian and South African children in the treatment-shortening SHINE trial. Methods Children weighing 4.0–7.9, 8.0–11.9, 12.0–15.9, or 16.0–24.9 kg received 1, 2, 3, or 4 tablets daily, respectively (rifampicin/isoniazid/pyrazinamide [75/50/150 mg], with or without 100 mg ethambutol, or rifampicin/isoniazid [75/50 mg]). Children 25.0–36.9 kg received doses recommended for adults <37 kg (300, 150, 800, and 550 mg/d, respectively, for rifampicin, isoniazid, pyrazinamide, and ethambutol). Pharmacokinetics were evaluated after at least 2 weeks of treatment. Results In the 77 children evaluated, the median age (interquartile range) was 3.7 (1.4–6.6) years; 40 (52%) were male and 20 (26%) were human immunodeficiency virus positive. The median area under the concentration-time curve from 0 to 24 hours for rifampicin, isoniazid, pyrazinamide, and ethambutol was 32.5 (interquartile range, 20.1–45.1), 16.7 (9.2–25.9), 317 (263–399), and 9.5 (7.5–11.5) mg⋅h/L, respectively, and lower in children than in adults for rifampicin in the 4.0–7.9-, 8–11.9-, and ≥25-kg weight bands, isoniazid in the 4.0–7.9-kg and ≥25-kg weight bands, and ethambutol in all 5 weight bands. Pyrazinamide exposures were similar to those in adults. Conclusions Recommended weight band–based FDC doses result in lower drug exposures in children in lower weight bands and in those ≥25 kg (receiving adult doses). Further adjustments to current doses are needed to match current target exposures in adults. The use of ethambutol at the current World Health Organization–recommended doses requires further evaluation. [ABSTRACT FROM AUTHOR]

Published
2022
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15. Microbial Translocation Does Not Drive Immune Activation in Ugandan Children Infected With HIV

Author

Fitzgerald, Felicity, Lhomme, Édouard, Harris, Kathryn, Doyle, Ronan, Shaw, Liam, Abongomera, George, Brown, Julia, Brooks, Anthony, Prendergast, Andrew, Thiébaut, A., Chintu, Chifumbe, Mulenga, Veronica, Kabamba, Desiree, Kavindele, Dorothy, Chabala, Chishala, Mwenechanya, Musaku, Kapasa, Monica, Zulu, Caroline, Kalumbi, Mox, Lungu, Joyce, Liusha, Marjory, Zangata, Dorothy, Masuka, Dorica, Chambula, Elias, Chanshi, Shadreck, Chipoya, Terence, Zulu, Semy, Chola, Daniel, Chanda, Betty, Malama, Steven, Chama, Chama, Mulambo, Sylvia, Mwanza, Mpala, Asiimwe, A, Tukei, J Vicent, Korutaro, Violet, Komunyena, Justine, Sebuliba, Isaac, Kisekka, Muzamil, Nansubuga, Carolyn, Mpanga, Justine, Matovu, Moses, Okello, Charles, Kesande, Sharon, Namutebi, Gladys, Tumuheirirwe, E Glorius, Nagawa, Immaculate, Nakimera, Sarah, Onen, Geoffrey, Kabasita, Fatuma, Sunday, Fred, Isabirye, Dick, Kityo, Cissy, Musiime, Victor, Mirembe, Grace, Kaudha, Elizabeth, Drasiku, A, Bainomuhwezi, Bernard, Wavamunno, Priscilla, Odongo, Florence, Lukowe, Constance, Namala, Winnie, Sseremba, Daniel, Balaba, A, Kwaga, A, Kayiwa, Joshua, Odera, Matthew, Oronon, Paul, Bagurukira, Edith, Mwesigwa, Phyllis, Apugulu, A, Mugarura, Lincoln, David Williams, Eram, Odoch, Denis, Nankya, Immaculate, Ndashimyeeva, Emmanuel, Nabulime, Eva, Abach, A, Agings Odong, A, Arach, A, Claren Aciro, A, Omongin, Joseph, Amone, A, Okello, Peter, Aleti, A, Otim, Edward, Kidega, Patrick, Achol, A, Mwape, Innocent, Zulu, Joshua, Chipili, Gabriel, Chibesa, Linda, Sarah Walker, A, Thomason, Margaret, Cook, Adrian, Owen-Powell, Ellen, Ferrier, A, Baptiste, David, Male, Charlotte, Murphy, Brendan, Spyer, Moira, Klein, Nigel, Burger, David, Fillekes, Quirine, Colbers, A, McIlleron, Helen, Chomba, Elwyn, Ramos, Jose, Akol, A, Elyanu, Peter, Nakimuli, Harriet, Kenny, Julia, Gibb, Diana, Université de Bordeaux (UB), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS), REDSIAM, groupe de travail infectieux, Joint Clinical Research Center, Infectious Diseases and Microbiology Unit, Institute of Child Health-Great Ormond Street Hospital for Children [London] (GOSH), Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, EA 4100, Histoire culturelle et sociale de l'art (HiCSA), and Université Paris 1 Panthéon-Sorbonne (UP1)-Université Paris 1 Panthéon-Sorbonne (UP1)

Subjects
[SDV]Life Sciences [q-bio], [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2018

17. Changes in body mass index and hemoglobin concentration in breastfeeding women living with HIV with a CD4 count over 350: Results from 4 African countries (The ANRS 12174 trial)

Author

Somé, Eric, Engebretsen, Ingunn Marie S., Nagot, Nicolas, Meda, Nicolas Y, Vallo, Roselyne, Kankasa, Chipepo, Tumwine, James K, Singata, Mandisa, Hofmeyr, Justus G, Van De Perre, Philippe, Tylleskär, Thorkild, Marechal, Valerie, Neveu, Dorine, Foulongne, Vincent, Segondy, Michel, Schaub, Roxanne, Blanche, Stephane, Treluyer, Jean-Marc, Hirt, Deborah, Karamagi, Charles, Musoke, Philippa, Ndeezi, Grace, Mugaba, Proscovia M, Kwagala, Mary, Murungi, Joan, Muweesi, Hawa Nabuuma, Ninsiima, Evelyn, Baryeija, Simon, Ouedraogo, Rasmata, Ye, Diarra, Traore, Hugues A, Nadembega, Christelle, Konate, Justin, Zongo, Arsene, Ouedraogo, Abass, Neboua, Desire, Belemvire, Aissatou, Bambara, Armel, Boncoungou, Justine, Zoungrana, Danielle, Nikodem, Cheryl, Harper, Kim, Jackson, Debra, Sanders, David, Sunday, Amwe, Okegbe-Eze, Collins, Williams, Xoliswa, Mshweshwe, Nolundi, Henge, Vatiswa, Gomba, Fikiswa, Nikodem, Lada, Khondowe, Oswell, Mwiya, Mwiya, Lusaka, Mildreed, Chizyuka, Mary, Phiri, Mary, Imakando, Billies, Musaku, Mwenechanya, Kapasa, Monica, Rutagwera, David, Clement, Ngondwe, Mwaba, Hilton Mwila, Matoba, Japhet, Mwaba, Hilton, Siumita, Chafye, Chola, Katai, Mwamutanda, Patricia, Pathogénèse et contrôle des infections chroniques (PCCI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)

Subjects
RNA viruses, Pediatrics, Physiology, Maternal Health, [SDV]Life Sciences [q-bio], Breastfeeding, lcsh:Medicine, HIV Infections, Pathology and Laboratory Medicine, Biochemistry, Geographical locations, Body Mass Index, Families, Hemoglobins, South Africa, 0302 clinical medicine, Endocrinology, Immunodeficiency Viruses, Interquartile range, Reproductive Physiology, Medicine and Health Sciences, Uganda, 030212 general & internal medicine, lcsh:Science, Children, 2. Zero hunger, Multidisciplinary, Lopinavir, 3. Good health, Breast Feeding, Medical Microbiology, Viral Pathogens, Cohort, Viruses, Female, Pathogens, Infants, medicine.drug, Research Article, Adult, medicine.medical_specialty, Anti-HIV Agents, 030231 tropical medicine, Zambia, Breast milk, Microbiology, 03 medical and health sciences, Young Adult, Acquired immunodeficiency syndrome (AIDS), Retroviruses, Burkina Faso, medicine, Lactation, Humans, Hemoglobin, Microbial Pathogens, Endocrine Physiology, business.industry, Lentivirus, lcsh:R, Organisms, Biology and Life Sciences, HIV, Proteins, medicine.disease, CD4 Lymphocyte Count, Age Groups, People and Places, Africa, Women's Health, Population Groupings, lcsh:Q, Neonatology, business, Breast feeding, Body mass index
Abstract

International audience; Breastfeeding is recommended for infants born to HIV-infected women in low-income settings. Both breastfeeding and HIV-infection are energy demanding. Our objective was to explore how exclusive and predominant breastfeeding changes body mass index (BMI) among breastfeeding HIV1-positive women participating in the ANRS12174 trial (clinical trial no NCT0064026). METHODS: HIV-positive women (n = 1 267) with CD4 count \textgreater350, intending to breastfeed HIV-negative infants were enrolled from Burkina Faso, South Africa, Uganda and Zambia and counselled on breastfeeding. N = 1 216 were included in the analysis. The trial compared Lamivudine and Lopinavir/Ritonavir as a peri-exposure prophylaxis. We ran a linear mixed-effect model with BMI as the dependent variable and exclusive or predominant breastfeeding duration as the key explanatory variable. RESULTS: Any breastfeeding or exclusive/predominant) breastfeeding was initiated by 99.6% and 98.6% of the mothers respectively in the first week after birth. The median (interquartile range: IQR) duration of the group that did any breastfeeding or the group that did exclusive /predominant breastfeeding were 9.5 (7.5; 10.6) and 5.8 (5.6; 5.9)) months, respectively. The median (IQR) age, BMI, CD4 count, and HIV viral load at baseline (day 7) were 27 (23.3; 31) years, 23.7 (21.3; 27.0) kg/m2, 530 (432.5; 668.5) cells/μl and 0.1 (0.8; 13.7)1000 copies/mL, respectively. No major change in mean BMI was seen in this cohort over a 50-week period during lactation. The mean change between 26 and 50 weeks after birth was 0.7 kg/m2. Baseline mean BMI (measured on day 7 postpartum) and CD4 count were positively associated with maternal BMI change, with a mean increase of 1.0 kg/m2 (0.9; 1.0) per each additional baseline-BMI kilogram and 0.3 kg/m2 (0.2; 0.5) for each additional CD4 cell/μl, respectively. CONCLUSION: Breastfeeding was not negatively correlated with the BMI of HIV-1 infected Sub-Saharan African mothers. However, a higher baseline BMI and a CD4 count \textgreater500 cells/μl were associated with maternal BMI during the exclusive/ predominant breastfeeding period. Considering the benefits of breast milk for the infants and the recurrent results from different studies that breastfeeding is not harmful to the HIV-1-infected mothers, this study also supports the WHO 2016 guidelines on infant feeding that mothers living with HIV should breastfeed where formula is not safe for at least 12 months and up to 24 months, given that the right treatment or prophylaxis for the infection is administered. These findings and conclusions cannot be extrapolated to women who are immune-compromised or have AIDS.

Published
2017
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18. Preventing Bloodstream Infections and Death in Zambian Neonates: Impact of a Low-cost Infection Control Bundle

Author

Mwananyanda, Lawrence, primary, Pierre, Cassandra, additional, Mwansa, James, additional, Cowden, Carter, additional, Localio, A Russell, additional, Kapasa, Monica L, additional, Machona, Sylvia, additional, Musyani, Chileshe Lukwesa, additional, Chilufya, Moses M, additional, Munanjala, Gertrude, additional, Lyondo, Angela, additional, Bates, Matthew A, additional, Coffin, Susan E, additional, and Hamer, Davidson H, additional

Published
2018
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20. Antenatal corticosteroids for women at risk of imminent preterm birth in low-resource countries: the case for equipoise and the need for efficacy trials

Author

Vogel, Joshua P, primary, Oladapo, Olufemi T, additional, Pileggi-Castro, Cynthia, additional, Adejuyigbe, Ebunoluwa A, additional, Althabe, Fernando, additional, Ariff, Shabina, additional, Ayede, Adejumoke Idowu, additional, Baqui, Abdullah H, additional, Costello, Anthony, additional, Chikamata, Davy M, additional, Crowther, Caroline, additional, Fawole, Bukola, additional, Gibbons, Luz, additional, Jobe, Alan H, additional, Kapasa, Monica Lulu, additional, Kinuthia, John, additional, Kriplani, Alka, additional, Kuti, Oluwafemi, additional, Neilson, James, additional, Patterson, Janna, additional, Piaggio, Gilda, additional, Qureshi, Rahat, additional, Qureshi, Zahida, additional, Sankar, Mari Jeeva, additional, Stringer, Jeffrey S A, additional, Temmerman, Marleen, additional, Yunis, Khalid, additional, Bahl, Rajiv, additional, and Metin Gülmezoglu, A, additional

Published
2017
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21. Etiology, Antibiotic Resistance and Risk Factors for Neonatal Sepsis in a Large Referral Center in Zambia

Author

Kabwe, Mwila, primary, Tembo, John, additional, Chilukutu, Lophina, additional, Chilufya, Moses, additional, Ngulube, Francis, additional, Lukwesa, Chileshe, additional, Kapasa, Monica, additional, Enne, Virve, additional, Wexner, Hannah, additional, Mwananyanda, Lawrence, additional, Hamer, Davidson H., additional, Sinyangwe, Sylvestor, additional, Ahmed, Yusuf, additional, Klein, Nigel, additional, Maeurer, Markus, additional, Zumla, Alimuddin, additional, and Bates, Matthew, additional

Published
2016
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22. Extended pre-exposure prophylaxis with lopinavir–ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial

Author

Nagot, Nicolas, primary, Kankasa, Chipepo, additional, Tumwine, James K, additional, Meda, Nicolas, additional, Hofmeyr, G Justus, additional, Vallo, Roselyne, additional, Mwiya, Mwiya, additional, Kwagala, Mary, additional, Traore, Hugues, additional, Sunday, Amwe, additional, Singata, Mandisa, additional, Siuluta, Chafye, additional, Some, Eric, additional, Rutagwera, David, additional, Neboua, Desire, additional, Ndeezi, Grace, additional, Jackson, Debra, additional, Maréchal, Valérie, additional, Neveu, Dorine, additional, Engebretsen, Ingunn M S, additional, Lombard, Carl, additional, Blanche, Stéphane, additional, Sommerfelt, Halvor, additional, Rekacewicz, Claire, additional, Tylleskär, Thorkild, additional, Van de Perre, Philippe, additional, Nagot, Nicolas, additional, Marechal, Valerie, additional, Peries, Marianne, additional, Foulongne, Vincent, additional, Segondy, Michel, additional, Blanche, Stephane, additional, Treluyer, Jean-Marc, additional, Hirt, Deborah, additional, Karamagi, Charles, additional, Musoke, Philippa, additional, Mugaba, Proscovia M, additional, Murungi, Joan, additional, Muweesi, Hawa Nabuuma, additional, Ninsiima, Evelyn, additional, Baryeija, Simon, additional, Juma, Frederic, additional, Kata, Caleb Bwengye, additional, Katushabe, Stuart, additional, Ouédraogo, Rasmata, additional, Yé, Diarra, additional, Somé, Eric, additional, Traoré, Hugues A, additional, Nadembega, Christelle, additional, Konaté, Justin, additional, Zongo, Arsène, additional, Ouédraogo, Abass, additional, Néboua, Désiré, additional, Bélemviré, Aissatou, additional, Bambara, Armel, additional, Boncoungou, Justine, additional, Zoungrana, Danielle, additional, Nikodem, Cheryl, additional, Hofmeyr, Justus, additional, Harper, Kim, additional, Sanders, David, additional, Aku, Amwe, additional, Okegbe-Eze, Collins, additional, Williams, Xoliswa, additional, Mshweshwe, Nolundi, additional, Henge, Vatiswa, additional, Gomba, Fikiswa, additional, Gundu, Tapiwa, additional, Khondowe, Oswell, additional, Lusaka, Mildred, additional, Chizyuka, Mary, additional, Phiri, Mary, additional, Imakando, Billies, additional, Musaku, Mwenechanya, additional, Kapasa, Monica, additional, Clement, Gondwe, additional, Mwaba, Hilton Mwila, additional, Matoba, Japhet, additional, Chola, Katai, additional, Mwamutanda, Patricia, additional, Engebretsen, Ingunn, additional, Klungsøyr, Jørn, additional, van den Broeck, Jan, additional, and Blume, Jörn, additional

Published
2016
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24. Additional file 1: of Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial

Author

Chishala Chabala, Turkova, Anna, Thomason, Margaret, Wobudeya, Eric, Hissar, Syed, Mave, Vidya, Zalm, Marieke Van Der, Palmer, Megan, Kapasa, Monica, Perumal Bhavani, Sarath Balaji, Raichur, Priyanka, Demers, Anne-Marie, Hoddinott, Graeme, Owen-Powell, Ellen, Kinikar, Aarti, Musoke, Philippa, Mulenga, Veronica, Aarnoutse, Rob, McIlleron, Helen, Hesseling, Anneke, Crook, Angela, Cotton, Mark, and Gibb, Diana

Subjects
3. Good health
Abstract

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 125 kb)

25. Additional file 1: of Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial

Author

Chishala Chabala, Turkova, Anna, Thomason, Margaret, Wobudeya, Eric, Hissar, Syed, Mave, Vidya, Zalm, Marieke Van Der, Palmer, Megan, Kapasa, Monica, Perumal Bhavani, Sarath Balaji, Raichur, Priyanka, Demers, Anne-Marie, Hoddinott, Graeme, Owen-Powell, Ellen, Kinikar, Aarti, Musoke, Philippa, Mulenga, Veronica, Aarnoutse, Rob, McIlleron, Helen, Hesseling, Anneke, Crook, Angela, Cotton, Mark, and Gibb, Diana

Subjects
3. Good health
Abstract

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 125 kb)

26. Preventing Bloodstream Infections and Death in Zambian Neonates: Impact of a Low-cost Infection Control Bundle

Author

Mwananyanda, Lawrence, Pierre, Cassandra, Mwansa, James, Cowden, Carter, Localio, A Russell, Kapasa, Monica L, Machona, Sylvia, Musyani, Chileshe Lukwesa, Chilufya, Moses M, Munanjala, Gertrude, Lyondo, Angela, Bates, Matthew, Coffin, Susan E, Hamer, Davidson H, Mwananyanda, Lawrence, Pierre, Cassandra, Mwansa, James, Cowden, Carter, Localio, A Russell, Kapasa, Monica L, Machona, Sylvia, Musyani, Chileshe Lukwesa, Chilufya, Moses M, Munanjala, Gertrude, Lyondo, Angela, Bates, Matthew, Coffin, Susan E, and Hamer, Davidson H

Abstract

Background Sepsis is a leading cause of neonatal mortality in low-resource settings. As facility-based births become more common, the proportion of neonatal deaths due to hospital-onset sepsis has increased. Methods We conducted a prospective cohort study in a neonatal intensive care unit in Zambia where we implemented a multi-faceted infection prevention and control (IPC) bundle consisting of IPC training, text message reminders, alcohol hand rub, enhanced environmental cleaning, and weekly bathing of babies ≥1.5 kg with 2% chlorhexidine gluconate. Hospital-associated sepsis, bloodstream infection (BSI), and mortality (>3 days after admission) outcome data were collected for 6 months prior to and 11 months after bundle implementation. Results Most enrolled neonates had a birthweight ≥1.5 kg (2131/2669, 79.8%). Hospital-associated mortality was lower during the intervention than baseline period (18.0% vs 23.6%). Total mortality was lower in the intervention than prior periods. Half of enrolled neonates (50.4%) had suspected sepsis; 40.8% of cultures were positive. Most positive blood cultures yielded a pathogen (409/549, 74.5%), predominantly Klebsiella pneumoniae (289/409, 70.1%). The monthly rate and incidence density rate of suspected sepsis were lower in the intervention period for all birthweight categories, except babies weighing <1.0 kg. The rate of BSI with pathogen was also lower in the intervention than baseline period. Conclusions A simple IPC bundle can reduce sepsis and death in neonates hospitalized in high-risk, low-resource settings. Further research is needed to validate these findings in similar settings and to identify optimal implementation strategies for improvement and sustainability. Clinical Trials Registration. NCT02386592.

27. Etiology, antibiotic resistance and risk factors for neonatal sepsis in a large referral center in Zambia

Author

Kabwe, Mwila, Tembo, John, Chilukutu, Lophina, Chilufya, Moses, Ngulube, Francis, Lukwesa, Chileshe, Kapasa, Monica, Enne, Virve, Wexner, Hannah, Mwananyanda, Lawrence, Hamer, Davidson H., Sinyangwe, Sylvestor, Ahmed, Yusuf, Klein, Nigel, Maeurer, Markus, Zumla, Alimuddin, Bates, Matthew, Kabwe, Mwila, Tembo, John, Chilukutu, Lophina, Chilufya, Moses, Ngulube, Francis, Lukwesa, Chileshe, Kapasa, Monica, Enne, Virve, Wexner, Hannah, Mwananyanda, Lawrence, Hamer, Davidson H., Sinyangwe, Sylvestor, Ahmed, Yusuf, Klein, Nigel, Maeurer, Markus, Zumla, Alimuddin, and Bates, Matthew

Abstract

Background: In sub-Saharan Africa, there is scanty data on the causes of neonatal sepsis and antimicrobial resistance among common invasive pathogens that might guide policy and practice. Methods: A cross-sectional observational prevalence and etiology study of neonates with suspected sepsis admitted to the neonatal intensive care unit, University Teaching Hospital, Lusaka, Zambia, between October 2013 and May 2014. Data from blood cultures and phenotypic antibiotic susceptibility testing were compared with multivariate analysis of risk factors for neonatal sepsis. Results: Of 313 neonates with suspected sepsis, 54% (170/313) were male; 20% (62/313) were born to HIV-positive mothers; 33% (103/313) had positive blood cultures, of which 85% (88/103) were early-onset sepsis. Klebsiella species was the most prevalent isolate, accounting for 75% (77/103) of cases, followed by coagulase-negative staphylococci 6% (7/103)], Staphylococcus aureus 6% (6/103)], Escherichia coli 5% (5/103)] and Candida species 5% (5/103)]. For Klebsiella species, antibiotic resistance ranged from 96%-99% for World Health Organizationrecommended first-line therapy (gentamicin and ampicillin/penicillin) to 94%-97% for third-generation cephalosporins. The prevalence of cultureconfirmed sepsis increased from 0 to 39% during the period December 2013 to March 2014, during which time mortality increased 29%-47%; 93% (14/15) of late-onset sepsis and 82% (37/45) of early-onset sepsis aged 4-7 days were admitted > 2 days before the onset of symptoms. Culture results for only 25% (26/103) of cases were available before discharge or death. Maternal HIV infection was associated with a reduced risk of neonatal sepsis odds ratio, 0.46 (0.23-0.93); P = 0.029]. Conclusions: Outbreaks of nosocomial multiantibiotic-resistant infections are an important cause of neonatal sepsis and associated mortality. Reduced risk of neonatal sepsis associated with maternal HIV infection is counterintuitive and requires further

28. High rates of congenital cytomegalovirus infection linked with maternal HIV infection among neonatal admissions at a large referral center in sub-Saharan Africa

Author

Mwaanza, Nyaxewo, Chilukutu, Lophina, Tembo, John, Kabwe, Mwila, Musonda, Kunda, Kapasa, Monica, Chabala, Chishala, Sinyangwe, Sylvester, Mwaba, Peter, Zumla, Alimuddin, Bates, Matthew, Mwaanza, Nyaxewo, Chilukutu, Lophina, Tembo, John, Kabwe, Mwila, Musonda, Kunda, Kapasa, Monica, Chabala, Chishala, Sinyangwe, Sylvester, Mwaba, Peter, Zumla, Alimuddin, and Bates, Matthew

Abstract

Background. Congenital cytomegalovirus (CMV) infection is the major infectious cause of birth defects and hearing loss globally. There is a growing recognition of the potential clinical impact of congenital CMV infections in high-seroprevalence settings. Methods. A cross-sectional study of neonatal admissions at a large referral center in sub-Saharan Africa to determine the prevalence of both symptomatic and asymptomatic congenital CMV infection was performed. Real-time polymerase chain reaction was used to screen DNA-extracted sera, urine, and saliva, and an enzyme-linked immunosorbent assay was used to screen serum samples for anti-CMV immunoglobulin M. Multivariate binary logistic regression was used to identify risk factors associated with increased odds of congenital CMV infection. Results. Congenital CMV was detected in 3.8% (15/395) of neonates. Among these infants, 6 of 15 (40%) presented with jaundice, 1 of whom also had petechiae. Congenital CMV infection was detected in 9 of 79 (11.4%; 95% confidence interval CI], 6.1%-20.3%) neonates born to human immunodeficiency virus (HIV)-infected mothers, and both maternal HIV (odds ratio OR], 6.661 95% CI, 2.126-20.876], P = .001) and jaundice (OR, 5.701 95% CI, 1.776-18.306], P = .003) were independently linked with significantly increased odds of congenital CMV infection. Conclusions. Congenital and early infant CMV infections may have important consequences for child health in sub-Saharan Africa and other high HIV and CMV seroprevalence populations globally.

29. Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children.

Author

Turkova A, Wills GH, Wobudeya E, Chabala C, Palmer M, Kinikar A, Hissar S, Choo L, Musoke P, Mulenga V, Mave V, Joseph B, LeBeau K, Thomason MJ, Mboizi RB, Kapasa M, van der Zalm MM, Raichur P, Bhavani PK, McIlleron H, Demers AM, Aarnoutse R, Love-Koh J, Seddon JA, Welch SB, Graham SM, Hesseling AC, Gibb DM, and Crook AM

Subjects
Adolescent, Africa, Child, Child, Preschool, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, India, Infant, Intention to Treat Analysis, Isoniazid administration & dosage, Male, Patient Acuity, Pyrazinamide administration & dosage, Rifampin administration & dosage, Treatment Outcome, Antitubercular Agents administration & dosage, Tuberculosis drug therapy
Abstract

Background: Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen., Methods: We conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-susceptible, smear-negative tuberculosis in Uganda, Zambia, South Africa, and India. Children younger than 16 years of age were randomly assigned to 4 months (16 weeks) or 6 months (24 weeks) of standard first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the World Health Organization. The primary efficacy outcome was unfavorable status (composite of treatment failure [extension, change, or restart of treatment or tuberculosis recurrence], loss to follow-up during treatment, or death) by 72 weeks, with the exclusion of participants who did not complete 4 months of treatment (modified intention-to-treat population). A noninferiority margin of 6 percentage points was used. The primary safety outcome was an adverse event of grade 3 or higher during treatment and up to 30 days after treatment., Results: From July 2016 through July 2018, a total of 1204 children underwent randomization (602 in each group). The median age of the participants was 3.5 years (range, 2 months to 15 years), 52% were male, 11% had human immunodeficiency virus infection, and 14% had bacteriologically confirmed tuberculosis. Retention by 72 weeks was 95%, and adherence to the assigned treatment was 94%. A total of 16 participants (3%) in the 4-month group had a primary-outcome event, as compared with 18 (3%) in the 6-month group (adjusted difference, -0.4 percentage points; 95% confidence interval, -2.2 to 1.5). The noninferiority of 4 months of treatment was consistent across the intention-to-treat, per-protocol, and key secondary analyses, including when the analysis was restricted to the 958 participants (80%) independently adjudicated to have tuberculosis at baseline. A total of 95 participants (8%) had an adverse event of grade 3 or higher, including 15 adverse drug reactions (11 hepatic events, all but 2 of which occurred within the first 8 weeks, when the treatments were the same in the two groups)., Conclusions: Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis. (Funded by the U.K. Medical Research Council and others; SHINE ISRCTN number, ISRCTN63579542.)., (Copyright © 2022 Massachusetts Medical Society.)

Published
2022
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