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1. Neonatal rotavirus vaccine (RV3-BB) immunogenicity and safety in a neonatal and infant administration schedule in Malawi: a randomised, double-blind, four-arm parallel group dose-ranging study

Author

Witte, Desiree, Handley, Amanda, Jere, Khuzwayo C, Bogandovic-Sakran, Nada, Mpakiza, Ashley, Turner, Ann, Pavlic, Daniel, Boniface, Karen, Mandolo, Jonathan, Ong, Darren Suryawijaya, Bonnici, Rhian, Justice, Frances, Bar-Zeev, Naor, Iturriza-Gomara, Miren, Ackland, Jim, Donato, Celeste M, Cowley, Daniel, Barnes, Graeme, Cunliffe, Nigel A, and Bines, Julie E

Published
2022
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2. Rotavirus-Specific Maternal Serum Antibodies and Vaccine Responses to RV3-BB Rotavirus Vaccine Administered in a Neonatal or Infant Schedule in Malawi.

Author

Morgan, Benjamin, Lyons, Eleanor A., Handley, Amanda, Bogdanovic-Sakran, Nada, Pavlic, Daniel, Witte, Desiree, Mandolo, Jonathan, Turner, Ann, Jere, Khuzwayo C., Justice, Frances, Ong, Darren Suryawijaya, Bonnici, Rhian, Boniface, Karen, Donato, Celeste M., Mpakiza, Ashley, Meyer, Anell, Bar-Zeev, Naor, Iturriza-Gomara, Miren, Cunliffe, Nigel A., and Danchin, Margaret

Subjects
ROTAVIRUS diseases, ROTAVIRUS vaccines, ENZYME-linked immunosorbent assay, VACCINE effectiveness, ANTIBODY formation
Abstract

High titres of rotavirus-specific maternal antibodies may contribute to lower rotavirus vaccine efficacy in low- and middle-income countries (LMICs). RV3-BB vaccine (G3P[6]) is based on a neonatal rotavirus strain that replicates well in the newborn gut in the presence of breast milk. This study investigated the association between maternal serum antibodies and vaccine response in infants administered the RV3-BB vaccine. Serum was collected antenatally from mothers of 561 infants enrolled in the RV3-BB Phase II study conducted in Blantyre, Malawi, and analysed for rotavirus-specific serum IgA and IgG antibodies using enzyme-linked immunosorbent assay. Infant vaccine take was defined as cumulative IgA seroconversion (≥3 fold increase) and/or stool vaccine shedding. Maternal IgA or IgG antibody titres did not have a negative impact on vaccine-like stool shedding at any timepoint. Maternal IgG (but not IgA) titres were associated with reduced take post dose 1 (p < 0.005) and 3 (p < 0.05) in the neonatal vaccine schedule group but not at study completion (week 18). In LMICs where high maternal antibodies are associated with low rotavirus vaccine efficacy, RV3-BB in a neonatal or infant vaccine schedule has the potential to provide protection against severe rotavirus disease. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Quantifying the Cost of Shigella Diarrhea in the Enterics for Global Health (EFGH) Shigella Surveillance Study

Author

Morozoff, Chloe, primary, Ahmed, Naveed, additional, Chinkhumba, Jobiba, additional, Islam, Md Taufiqul, additional, Jallow, Abdoulie F, additional, Ogwel, Billy, additional, Zegarra Paredes, Loyda Fiorella, additional, Sanogo, Doh, additional, Atlas, Hannah E, additional, Badji, Henry, additional, Bar-Zeev, Naor, additional, Conteh, Bakary, additional, Güimack Fajardo, Mario, additional, Feutz, Erika, additional, Haidara, Fadima C, additional, Karim, Mehrab, additional, Mamby Keita, Adama, additional, Keita, Youssouf, additional, Khanam, Farhana, additional, Kosek, Margaret N, additional, Kotloff, Karen L, additional, Maguire, Rebecca, additional, Mbutuka, Ishmail S, additional, Ndalama, Maureen, additional, Ochieng, John Benjamin, additional, Okello, Collins, additional, Omore, Richard, additional, Perez Garcia, Karin F, additional, Qamar, Farah Naz, additional, Qudrat-E-Khuda, Syed, additional, Qureshi, Sonia, additional, Rajib, Md Nazmul Hasan, additional, Shapiama Lopez, Wagner Valentino, additional, Sultana, Shazia, additional, Witte, Desiree, additional, Yousafzai, Mohammad Tahir, additional, Awuor, Alex O, additional, Cunliffe, Nigel A, additional, Jahangir Hossain, M, additional, Paredes Olortegui, Maribel, additional, Tapia, Milagritos D, additional, Zaman, K, additional, and Means, Arianna Rubin, additional

Published
2024
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4. The Enterics for Global Health (EFGH) Shigella Surveillance Study in Malawi

Author

Mategula, Donnie, primary, Ndalama, Maureen, additional, Lefu, Clement, additional, Chinkhumba, Jobiba, additional, Ndeketa, Latif, additional, Munthali, Vitumbiko, additional, Chitala, Clifford, additional, Malemia, Thandizo, additional, Million, Gertrude, additional, Mbutuka, Ishmail, additional, Mhone, Ranken, additional, Makwenda, Ethel, additional, James, Mussa, additional, Bwanali, Cornelius, additional, Kazembe, Gift, additional, Manundo, Abell, additional, Chauluka, Evance, additional, Chitalo, Salama, additional, Alumando, Ethel, additional, Longwe, Dalitso, additional, Matandika, Maggie, additional, Jonasi, Paul, additional, Thindwa, Agra, additional, Phiri, Deborah, additional, Wachepa, Richard, additional, Kawonga, Flywell, additional, Maiden, Victor, additional, Charles, Mary, additional, Kapindula, Ida, additional, Witte, Desiree, additional, Turner, Ann M, additional, Bronowski, Christina, additional, Baker, Kate, additional, Bar-Zeev, Naor, additional, Gordon, Melita A, additional, Dube, Queen, additional, Cunliffe, Nigel A, additional, Jere, Khuzwayo C, additional, and Cornick, Jennifer, additional

Published
2024
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5. Diarrhea Case Surveillance in the Enterics for Global Health Shigella Surveillance Study: Epidemiologic Methods

Author

Atlas, Hannah E, primary, Conteh, Bakary, additional, Islam, Md Taufiqul, additional, Jere, Khuzwayo C, additional, Omore, Richard, additional, Sanogo, Doh, additional, Schiaffino, Francesca, additional, Yousafzai, Mohammad Tahir, additional, Ahmed, Naveed, additional, Awuor, Alex O, additional, Badji, Henry, additional, Cornick, Jennifer, additional, Feutz, Erika, additional, Galagan, Sean R, additional, Haidara, Fadima C, additional, Horne, Bri’Anna, additional, Hossen, Md Ismail, additional, Hotwani, Aneeta, additional, Houpt, Eric R, additional, Jallow, Abdoulie F, additional, Karim, Mehrab, additional, Keita, Adama Mamby, additional, Keita, Youssouf, additional, Khanam, Farhana, additional, Liu, Jie, additional, Malemia, Thandizo, additional, Manneh, Alhagie, additional, McGrath, Christine J, additional, Nasrin, Dilruba, additional, Ndalama, Maureen, additional, Ochieng, John Benjamin, additional, Ogwel, Billy, additional, Paredes Olortegui, Maribel, additional, Zegarra Paredes, Loyda Fiorella, additional, Pinedo Vasquez, Tackeshy, additional, Platts-Mills, James A, additional, Qudrat-E-Khuda, Syed, additional, Qureshi, Sonia, additional, Hasan Rajib, Md Nazmul, additional, Rogawski McQuade, Elizabeth T, additional, Sultana, Shazia, additional, Tennant, Sharon M, additional, Tickell, Kirkby D, additional, Witte, Desiree, additional, Peñataro Yori, Pablo, additional, Cunliffe, Nigel A, additional, Hossain, M Jahangir, additional, Kosek, Margaret N, additional, Kotloff, Karen L, additional, Qadri, Firdausi, additional, Qamar, Farah Naz, additional, Tapia, Milagritos D, additional, and Pavlinac, Patricia B, additional

Published
2024
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6. Data Management in Multicountry Consortium Studies: The Enterics For Global Health (EFGH) Shigella Surveillance Study Example

Author

Feutz, Erika, primary, Biswas, Prasanta K, additional, Ndeketa, Latif, additional, Ogwel, Billy, additional, Onwuchekwa, Uma, additional, Sarwar, Golam, additional, Sultana, Shazia, additional, Peñataro Yori, Pablo, additional, Acebedo, Alyssa, additional, Ahmed, Naveed, additional, Ahmed, Imran, additional, Atlas, Hannah E, additional, Awuor, Alex O, additional, Bhuiyan, Md Amirul Islam, additional, Conteh, Bakary, additional, Diawara, Oualy, additional, Elwood, Sarah, additional, Fane, Moussa, additional, Hossen, Md Ismail, additional, Ireen, Mahzabeen, additional, Jallow, Abdoulie F, additional, Karim, Mehrab, additional, Kosek, Margaret N, additional, Kotloff, Karen L, additional, Lefu, Clement, additional, Liu, Jie, additional, Maguire, Rebecca, additional, Qamar, Farah Naz, additional, Ndalama, Maureen, additional, Ochieng, John Benjamin, additional, Okonji, Caleb, additional, Paredes, Loyda Fiorella Zegarra, additional, Pavlinac, Patricia B, additional, Perez, Karin, additional, Qureshi, Sonia, additional, Schiaffino, Francesca, additional, Traore, Moussa, additional, Tickell, Kirkby D, additional, Wachepa, Richard, additional, Witte, Desiree, additional, Cornick, Jennifer, additional, Jahangir Hossain, M, additional, Khanam, Farhana, additional, Olortegui, Maribel Paredes, additional, Omore, Richard, additional, Sow, Samba O, additional, Yousafzai, Mohammad Tahir, additional, and Galagan, Sean R, additional

Published
2024
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7. Different clinical features in Malawian outpatients presenting with COVID-19 prior to and during Omicron variant dominance: A prospective observational study

Author

Epi Infectieziekten Team 1, Chibwana, Marah G., Thole, Herbert W., Anscombe, Cat, Ashton, Philip M., Green, Edward, Barnes, Kayla G., Cornick, Jen, Turner, Ann, Witte, Desiree, Nthala, Sharon, Thom, Chikondi, Kanyandula, Felistas, Ainani, Anna, Mtike, Natasha, Tambala, Hope, N'goma, Veronica, Mwafulirwa, Dorah, Asima, Erick, Morton, Ben, Gmeiner, Markus, Gundah, Zaziwe, Kawalazira, Gift, French, Neil, Feasey, Nicholas, Heyderman, Robert S., Swarthout, Todd D., Jambo, Kondwani C., Epi Infectieziekten Team 1, Chibwana, Marah G., Thole, Herbert W., Anscombe, Cat, Ashton, Philip M., Green, Edward, Barnes, Kayla G., Cornick, Jen, Turner, Ann, Witte, Desiree, Nthala, Sharon, Thom, Chikondi, Kanyandula, Felistas, Ainani, Anna, Mtike, Natasha, Tambala, Hope, N'goma, Veronica, Mwafulirwa, Dorah, Asima, Erick, Morton, Ben, Gmeiner, Markus, Gundah, Zaziwe, Kawalazira, Gift, French, Neil, Feasey, Nicholas, Heyderman, Robert S., Swarthout, Todd D., and Jambo, Kondwani C.

Published
2023

9. Different clinical features in Malawian outpatients presenting with COVID-19 prior to and during Omicron variant dominance: A prospective observational study

Author

Chibwana, Marah G., primary, Thole, Herbert W., additional, Anscombe, Cat, additional, Ashton, Philip M., additional, Green, Edward, additional, Barnes, Kayla G., additional, Cornick, Jen, additional, Turner, Ann, additional, Witte, Desiree, additional, Nthala, Sharon, additional, Thom, Chikondi, additional, Kanyandula, Felistas, additional, Ainani, Anna, additional, Mtike, Natasha, additional, Tambala, Hope, additional, N’goma, Veronica, additional, Mwafulirwa, Dorah, additional, Asima, Erick, additional, Morton, Ben, additional, Gmeiner, Markus, additional, Gundah, Zaziwe, additional, Kawalazira, Gift, additional, French, Neil, additional, Feasey, Nicholas, additional, Heyderman, Robert S., additional, Swarthout, Todd D., additional, and Jambo, Kondwani C., additional

Published
2023
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10. Differential symptoms among COVID-19 outpatients before and during periods of SARS-CoV-2 Omicron variant dominance in Blantyre, Malawi: a prospective observational study

Author

Chibwana, Marah G., primary, Thole, Herbert W., additional, Anscombe, Cat, additional, Ashton, Philip M., additional, Green, Edward, additional, Barnes, Kayla G., additional, Cornick, Jen, additional, Turner, Ann, additional, Witte, Desiree, additional, Nthala, Sharon, additional, Thom, Chikondi, additional, Kanyandula, Felistas, additional, Ainani, Anna, additional, Mtike, Natasha, additional, Tambala, Hope, additional, N’goma, Veronica, additional, Mwafulirwa, Dorah, additional, Asima, Erick, additional, Morton, Ben, additional, Gmeiner, Markus, additional, Gundah, Zaziwe, additional, Kawalazira, Gift, additional, French, Neil, additional, Feasey, Nicholas, additional, Heyderman, Robert S., additional, Swarthout, Todd D, additional, and Jambo, Kondwani C., additional

Published
2022
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13. Effect of 3 Days of Oral Azithromycin on Young Children With Acute Diarrhea in Low-Resource Settings A Randomized Clinical Trial

Author

Ahmed, Tahmeed, Chisti, Mohammod Jobayer, Rahman, Muhammad Waliur, Alam, Tahmina, Ahmed, Dilruba, Parvin, Irin, Kabir, Md Farhad, Sazawal, Sunil, Dhingra, Pratibha, Dutta, Arup, Deb, Saikat, Chouhan, Aishwarya, Sharma, Anil Kumar, Jaiswal, Vijay Kumar, Dhingra, Usha, Walson, Judd L, Singa, Benson O, Pavlinac, Patricia B, McGrath, Christine J, Nyabinda, Churchil, Deichsel, Emily L, Anyango, Maurine, Kariuki, Kevin Mwangi, Rwigi, Doreen, Tornberg-Belanger, Stephanie N, Kotloff, Karen L, Sow, Samba O, Tapia, Milagritos D, Haidara, FadimaCheick, Mehta, Ashka, Coulibaly, Flanon, Badji, Henry, Permala-Booth, Jasnehta, Tennant, Sharon M, Malle, Dramane, Bar-Zeev, Naor, Dube, Queen, Freyne, Bridget, Cunliffe, Nigel, Ndeketa, Latif, Witte, Desiree, Ndamala, Chifundo, Cornick, Jennifer, Qamar, Farah Naz, Yousafzai, Mohammad Tahir, Qureshi, Shahida, Shakoor, Sadia, Thobani, Rozina, Hotwani, Aneeta, Kabir, Furqan, Mohammed, Jan, Manji, Karim, Duggan, Christopher P, Kisenge, Rodrick, Sudfeld, Christopher R, Kibwana, Upendo, Somji, Sarah, Bakari, Mohamed, Msemwa, Cecylia, Samma, Abraham, Bahl, Rajiv, De Costa, Ayesha, Simon, Jonathon, Ashorn, Per, ABCD, Antibiotics Children Diarrhea, Tampere University, and Clinical Medicine

Subjects
Diarrhea, Male, Dehydration, Research, Malnutrition, Administration, Oral, Infant, General Medicine, Azithromycin, 3121 Internal medicine, Pediatrics, Drug Administration Schedule, Anti-Bacterial Agents, Online Only, Child Development, Treatment Outcome, Double-Blind Method, 3123 Gynaecology and paediatrics, Acute Disease, Ambulatory Care, Health Resources, Humans, Female, Original Investigation
Abstract

Key Points Question Does the addition of azithromycin to the standard case management of acute watery diarrhea for children aged 2 to 23 months who are dehydrated or undernourished reduce mortality and improve linear growth? Findings This randomized clinical trial of 8266 children was unable to detect a survival benefit for children from the addition of azithromycin to the standard World Health Organization (WHO) case management of acute watery diarrhea in low-resource settings. Meaning In low-resource settings, adherence to current WHO case management protocols for watery diarrhea remains appropriate; antibiotic use is not warranted., Importance World Health Organization (WHO) guidelines do not recommend routine antibiotic use for children with acute watery diarrhea. However, recent studies suggest that a significant proportion of such episodes have a bacterial cause and are associated with mortality and growth impairment, especially among children at high risk of diarrhea-associated mortality. Expanding antibiotic use among dehydrated or undernourished children may reduce diarrhea-associated mortality and improve growth. Objective To determine whether the addition of azithromycin to standard case management of acute nonbloody watery diarrhea for children aged 2 to 23 months who are dehydrated or undernourished could reduce mortality and improve linear growth. Design, Setting, and Participants The Antibiotics for Children with Diarrhea (ABCD) trial was a multicountry, randomized, double-blind, clinical trial among 8266 high-risk children aged 2 to 23 months presenting with acute nonbloody diarrhea. Participants were recruited between July 1, 2017, and July 10, 2019, from 36 outpatient hospital departments or community health centers in a mixture of urban and rural settings in Bangladesh, India, Kenya, Malawi, Mali, Pakistan, and Tanzania. Each participant was followed up for 180 days. Primary analysis included all randomized participants by intention to treat. Interventions Enrolled children were randomly assigned to receive either oral azithromycin, 10 mg/kg, or placebo once daily for 3 days in addition to standard WHO case management protocols for the management of acute watery diarrhea. Main Outcomes and Measures Primary outcomes included all-cause mortality up to 180 days after enrollment and linear growth faltering 90 days after enrollment. Results A total of 8266 children (4463 boys [54.0%]; mean [SD] age, 11.6 [5.3] months) were randomized. A total of 20 of 4133 children in the azithromycin group (0.5%) and 28 of 4135 children in the placebo group (0.7%) died (relative risk, 0.72; 95% CI, 0.40-1.27). The mean (SD) change in length-for-age z scores 90 days after enrollment was –0.16 (0.59) in the azithromycin group and −0.19 (0.60) in the placebo group (risk difference, 0.03; 95% CI, 0.01-0.06). Overall mortality was much lower than anticipated, and the trial was stopped for futility at the prespecified interim analysis. Conclusions and Relevance The study did not detect a survival benefit for children from the addition of azithromycin to standard WHO case management of acute watery diarrhea in low-resource settings. There was a small reduction in linear growth faltering in the azithromycin group, although the magnitude of this effect was not likely to be clinically significant. In low-resource settings, expansion of antibiotic use is not warranted. Adherence to current WHO case management protocols for watery diarrhea remains appropriate and should be encouraged. Trial Registration ClinicalTrials.gov Identifier: NCT03130114, This randomized clinical trial examines whether the addition of azithromycin to standard case management of acute nonbloody watery diarrhea for children aged 2 to 23 months who are dehydrated or undernourished could reduce mortality and improve linear growth.

Published
2021

14. Effect of human rotavirus vaccine on severe diarrhea in African infants

Author

Madhi, Shabir A., Cunliffe, Nigel A., Steele, Duncan, Witte, Desiree, Kirsten, Mari, Louw, Cheryl, Ngwira, Bagrey, Victor, John C., Gillard, Paul H., Cheuvart, Brigitte B., Han, Htay H., and Neuzil, Kathleen M.

Subjects
Children -- Health aspects, Diarrhea -- Care and treatment, Gastroenteritis -- Causes of, Gastroenteritis -- Prevention, Rotavirus infections -- Risk factors, Vaccines -- Usage
Abstract

A study was conducted to evaluate the efficacy and safety of the human rotavirus vaccine in African children suffering from severe diarrhea. Results indicated that the vaccine significantly reduce the incidence of severe rotavirus gastroenteritis among African children.

Published
2010

15. Neonatal Rotavirus Vaccine (RV3-BB) Immunogenicity and Safety in a Neonatal and Infant Administration Schedule in Malawi:&nbsp;A Randomized, Double-Blind, Four-Arm Parallel Group Dose-Ranging Study

Author

Witte, Desiree, primary, Handley, Amanda, additional, Jere, Khuzwayo C., additional, Bogandovic-Sakran, Nada, additional, Mpakiza, Ashley, additional, Turner, Ann, additional, Pavlic, Daniel, additional, Boniface, Karen, additional, Mandolo, Jonathan, additional, Suryawijaya Ong, Darren, additional, Bonnici, Rhian, additional, Justice, Frances, additional, Bar-Zeev, Naor, additional, Iturriza-Gómara, Miren, additional, Ackland, Jim, additional, Donato, Celeste M., additional, Cowley, Daniel, additional, Barnes, Graeme, additional, Cunliffe, Nigel A., additional, and Bines, Julie E., additional

Published
2021
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17. Human rotavirus vaccine Rotarix™ provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial

Author

Steele Andrew, Neuzil Kathleen M, Cunliffe Nigel A, Madhi Shabir A, Bos Pieter, Ngwira Bagrey, Witte Desiree, Todd Stacy, Louw Cheryl, Kirsten Mari, Aspinall Sanet, Van Doorn Leen, Bouckenooghe Alain, Suryakiran Pemmaraju V, and Han Htay

Subjects
Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Africa and Malawi. This paper examines rotavirus vaccine efficacy in preventing severe rotavirus gastroenteritis, during infancy, caused by the various G and P rotavirus types encountered during the first rotavirus-season. Methods Healthy infants aged 5–10 weeks were enrolled and randomized into three groups to receive either two (10 and 14 weeks) or three doses of Rotarix™ (together forming the pooled Rotarix™ group) or three doses of placebo at a 6,10,14-week schedule. Weekly home visits were conducted to identify gastroenteritis episodes. Rotaviruses were detected by ELISA and genotyped by RT-PCR and nucleotide sequencing. The percentage of infants with severe rotavirus gastroenteritis caused by the circulating G and P types from 2 weeks post-last dose until one year of age and the corresponding vaccine efficacy was calculated with 95% CI. Results Overall, 4939 infants were vaccinated and 4417 (pooled Rotarix™ = 2974; placebo = 1443) were included in the per protocol efficacy cohort. G1 wild-type was detected in 23 (1.6%) severe rotavirus gastroenteritis episodes from the placebo group. This was followed in order of detection by G12 (15 [1%] in placebo) and G8 types (15 [1%] in placebo). Vaccine efficacy against G1 wild-type, G12 and G8 types were 64.1% (95% CI: 29.9%; 82%), 51.5% (95% CI:-6.5%; 77.9%) and 64.4% (95% CI: 17.1%; 85.2%), respectively. Genotype P[8] was the predominant circulating P type and was detected in 38 (2.6%) severe rotavirus gastroenteritis cases in placebo group. The remaining circulating P types comprised of P[4] (20 [1.4%] in placebo) and P[6] (13 [0.9%] in placebo). Vaccine efficacy against P[8] was 59.1% (95% CI: 32.8%; 75.3%), P[4] was 70.9% (95% CI: 37.5%; 87.0%) and P[6] was 55.2% (95% CI: -6.5%; 81.3%) Conclusions Rotarix™ vaccine demonstrated efficacy against severe gastroenteritis caused by diverse circulating rotavirus types. These data add to a growing body of evidence supporting heterotypic protection provided by Rotarix™. Trial registration number NCT00241644

Published
2012
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18. Safety and Immunogenicity of Seven Dosing Regimens of the Candidate RTS,S/AS01E Malaria Vaccine Integrated Within an Expanded Program on Immunization Regimen

Author

Witte, Desiree, primary, Cunliffe, Nigel A., additional, Turner, Ann M., additional, Ngulube, Edward, additional, Ofori-Anyinam, Opokua, additional, Vekemans, Johan, additional, Chimpeni, Philips, additional, Lievens, Marc, additional, Wilson, Trevor P., additional, Njiram’madzi, Jenala, additional, Mendoza, Yolanda Guerra, additional, and Leach, Amanda, additional

Published
2018
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19. Safety and Immunogenicity of Seven Dosing Regimens of the Candidate RTS,S/AS01EMalaria Vaccine Integrated Within an Expanded Program on Immunization Regimen

Author

Witte, Desiree, Cunliffe, Nigel A., Turner, Ann M., Ngulube, Edward, Ofori-Anyinam, Opokua, Vekemans, Johan, Chimpeni, Philips, Lievens, Marc, Wilson, Trevor P., Njiram’madzi, Jenala, Mendoza, Yolanda Guerra, and Leach, Amanda

Abstract

Supplemental Digital Content is available in the text.

Published
2018
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21. Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian children in the first two years of life: A randomized, double-blind, placebo controlled trial

Author

Cunliffe, Nigel A., primary, Witte, Desiree, additional, Ngwira, Bagrey M., additional, Todd, Stacy, additional, Bostock, Nancy J., additional, Turner, Ann M., additional, Chimpeni, Philips, additional, Victor, John C., additional, Steele, A. Duncan, additional, Bouckenooghe, Alain, additional, and Neuzil, Kathleen M., additional

Published
2012
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23. Effect of 3 Days of Oral Azithromycin on Young Children With Acute Diarrhea in Low-Resource Settings: A Randomized Clinical Trial.

Author

Ahmed T, Chisti MJ, Rahman MW, Alam T, Ahmed D, Parvin I, Kabir MF, Sazawal S, Dhingra P, Dutta A, Deb S, Chouhan A, Sharma AK, Jaiswal VK, Dhingra U, Walson JL, Singa BO, Pavlinac PB, McGrath CJ, Nyabinda C, Deichsel EL, Anyango M, Kariuki KM, Rwigi D, Tornberg-Belanger SN, Kotloff KL, Sow SO, Tapia MD, Haidara FC, Mehta A, Coulibaly F, Badji H, Permala-Booth J, Tennant SM, Malle D, Bar-Zeev N, Dube Q, Freyne B, Cunliffe N, Ndeketa L, Witte D, Ndamala C, Cornick J, Qamar FN, Yousafzai MT, Qureshi S, Shakoor S, Thobani R, Hotwani A, Kabir F, Mohammed J, Manji K, Duggan CP, Kisenge R, Sudfeld CR, Kibwana U, Somji S, Bakari M, Msemwa C, Samma A, Bahl R, De Costa A, Simon J, and Ashorn P

Subjects
Acute Disease, Administration, Oral, Ambulatory Care statistics & numerical data, Dehydration complications, Dehydration mortality, Diarrhea etiology, Diarrhea mortality, Double-Blind Method, Drug Administration Schedule, Female, Health Resources supply & distribution, Humans, Infant, Male, Malnutrition complications, Malnutrition mortality, Treatment Outcome, Anti-Bacterial Agents administration & dosage, Azithromycin administration & dosage, Child Development drug effects, Diarrhea drug therapy
Abstract

Importance: World Health Organization (WHO) guidelines do not recommend routine antibiotic use for children with acute watery diarrhea. However, recent studies suggest that a significant proportion of such episodes have a bacterial cause and are associated with mortality and growth impairment, especially among children at high risk of diarrhea-associated mortality. Expanding antibiotic use among dehydrated or undernourished children may reduce diarrhea-associated mortality and improve growth., Objective: To determine whether the addition of azithromycin to standard case management of acute nonbloody watery diarrhea for children aged 2 to 23 months who are dehydrated or undernourished could reduce mortality and improve linear growth., Design, Setting, and Participants: The Antibiotics for Children with Diarrhea (ABCD) trial was a multicountry, randomized, double-blind, clinical trial among 8266 high-risk children aged 2 to 23 months presenting with acute nonbloody diarrhea. Participants were recruited between July 1, 2017, and July 10, 2019, from 36 outpatient hospital departments or community health centers in a mixture of urban and rural settings in Bangladesh, India, Kenya, Malawi, Mali, Pakistan, and Tanzania. Each participant was followed up for 180 days. Primary analysis included all randomized participants by intention to treat., Interventions: Enrolled children were randomly assigned to receive either oral azithromycin, 10 mg/kg, or placebo once daily for 3 days in addition to standard WHO case management protocols for the management of acute watery diarrhea., Main Outcomes and Measures: Primary outcomes included all-cause mortality up to 180 days after enrollment and linear growth faltering 90 days after enrollment., Results: A total of 8266 children (4463 boys [54.0%]; mean [SD] age, 11.6 [5.3] months) were randomized. A total of 20 of 4133 children in the azithromycin group (0.5%) and 28 of 4135 children in the placebo group (0.7%) died (relative risk, 0.72; 95% CI, 0.40-1.27). The mean (SD) change in length-for-age z scores 90 days after enrollment was -0.16 (0.59) in the azithromycin group and -0.19 (0.60) in the placebo group (risk difference, 0.03; 95% CI, 0.01-0.06). Overall mortality was much lower than anticipated, and the trial was stopped for futility at the prespecified interim analysis., Conclusions and Relevance: The study did not detect a survival benefit for children from the addition of azithromycin to standard WHO case management of acute watery diarrhea in low-resource settings. There was a small reduction in linear growth faltering in the azithromycin group, although the magnitude of this effect was not likely to be clinically significant. In low-resource settings, expansion of antibiotic use is not warranted. Adherence to current WHO case management protocols for watery diarrhea remains appropriate and should be encouraged., Trial Registration: ClinicalTrials.gov Identifier: NCT03130114.

Published
2021
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