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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high-risk young children with non-bloody diarrhoea in low resource settings: The Antibiotics for Children with Diarrhoea (ABCD) trial protocol
Trials, Volume 21, No. 1, Article 71, Year 2020
Notification
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Description
Background: Acute diarrhoea is a common cause of illness and death among children in low- to middle-income settings. World Health Organization guidelines for the clinical management of acute watery diarrhoea in children focus on oral rehydration, supplemental zinc and feeding advice. Routine use of antibiotics is not recommended except when diarrhoea is bloody or cholera is suspected. Young children who are undernourished or have a dehydrating diarrhoea are more susceptible to death at 90 days after onset of diarrhoea. Given the mortality risk associated with diarrhoea in children with malnutrition or dehydrating diarrhoea, expanding the use of antibiotics for this subset of children could be an important intervention to reduce diarrhoea-associated mortality and morbidity. We designed the Antibiotics for Childhood Diarrhoea (ABCD) trial to test this intervention. Methods: ABCD is a double-blind, randomised trial recruiting 11,500 children aged 2-23 months presenting with acute non-bloody diarrhoea who are dehydrated and/or undernourished (i.e. have a high risk for mortality). Enrolled children in Bangladesh, India, Kenya, Malawi, Mali, Pakistan and Tanzania are randomised (1:1) to oral azithromycin 10 mg/kg or placebo once daily for 3 days and followed-up for 180 days. Primary efficacy endpoints are all-cause mortality during the 180 days post-enrolment and change in linear growth 90 days post-enrolment. Discussion: Expanding the treatment of acute watery diarrhoea in high-risk children to include an antibiotic may offer an opportunity to reduce deaths. These benefits may result from direct antimicrobial effects on pathogens or other incompletely understood mechanisms including improved nutrition, alterations in immune responsiveness or improved enteric function. The expansion of indications for antibiotic use raises concerns about the emergence of antimicrobial resistance both within treated children and the communities in which they live. ABCD will monitor antimicrobial resistance. The ABCD trial has important policy implications. If the trial shows significant benefits of azithromycin use, this may provide evidence to support reconsideration of antibiotic indications in the present World Health Organization diarrhoea management guidelines. Conversely, if there is no evidence of benefit, these results will support the current avoidance of antibiotics except in dysentery or cholera, thereby avoiding inappropriate use of antibiotics and reaffirming the current guidelines. Trial registration: Clinicaltrials.gov, NCT03130114. Registered on April 26 2017. © 2020 The Author(s).
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC6956478/bin/13063_2019_3829_MOESM1_ESM.doc
Authors & Co-Authors
Alam, Tahmina
Unknown Affiliation
Ahmed, Dilruba
Unknown Affiliation
Ahmed, Tahmeed
Unknown Affiliation
CHISTI, M. J.
Unknown Affiliation
Rahman, Muhammad Waliur
Unknown Affiliation
Chouhan, Aishwarya
Unknown Affiliation
Deb, Saikat
Unknown Affiliation
Dhingra, Pratibha N.
Unknown Affiliation
Dhingra, Usha
Unknown Affiliation
Dutta, Arup
Unknown Affiliation
Jaiswal, Vikash K.
Unknown Affiliation
Kumar, Jitendra
Unknown Affiliation
Sazawal, Sunil
Unknown Affiliation
McGrath, Christine J.
Unknown Affiliation
Nyabinda, Churchil
Unknown Affiliation
Okello, Mark
Unknown Affiliation
Pavlinac, Patricia B.
Unknown Affiliation
Singa, Benson O.
Unknown Affiliation
Walson, Judd L.
Unknown Affiliation
Bar-Zeev, Naor
Unknown Affiliation
Dube, Queen Felix
Unknown Affiliation
Freyne, Bridget Joan
Unknown Affiliation
Ndamala, Chifundo B.
Unknown Affiliation
Ndeketa, Latif
Unknown Affiliation
Badji, Henry
Unknown Affiliation
Coulibaly, Flanon
Unknown Affiliation
Haidara, Fadima Cheick
Unknown Affiliation
Kotloff, Karen L.
Unknown Affiliation
Malle, Dramane
Unknown Affiliation
Mehta, Ashka
Unknown Affiliation
Sow, Samba Ousmane
Unknown Affiliation
Tapia, Milagritos D.
Unknown Affiliation
Tennant, Sharon M.
Unknown Affiliation
Hotwani, Aneeta
Unknown Affiliation
Kabir, Furqan
Unknown Affiliation
Qamar, Farah Naz
Unknown Affiliation
Qureshi, Sonia
Unknown Affiliation
Shakoor’, Sadia
Unknown Affiliation
Thobani, Rozina S.
Unknown Affiliation
Bakari, Muhammad
Unknown Affiliation
Duggan, Christopher P.
Unknown Affiliation
Kibwana, Upendo Ozeniel
Unknown Affiliation
Kisenge, Rodrick R.
Unknown Affiliation
Manji, Karim Premji
Unknown Affiliation
Somji, Sarah S.
Unknown Affiliation
Sudfeld, Christopher Robert
Unknown Affiliation
Ashorn, Per A.
Unknown Affiliation
Bahl, Rajiv
Unknown Affiliation
de Costa, Ayesha
Switzerland, Geneva
Organisation Mondiale de la Santé
Simon, Jonathon L.
Unknown Affiliation
Statistics
Citations: 2
Authors: 50
Affiliations: 1
Identifiers
Doi:
10.1186/s13063-019-3829-y
ISSN:
17456215
Research Areas
Disability
Food Security
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Kenya
Malawi
Mali
Tanzania