NCT03130114: ABCD

Antibiotics for Children With Severe Diarrhoea

Completed Phase 3 Last updated 19 May 2020

What this trial tests

Phase 3 trial testing Azithromycin in Diarrhea in 8,268 participants. Completed in 15 January 2020.

Timeline

13 May 2017

Primary endpoint
15 January 2020

15 January 2020

Quick facts

Lead sponsor	World Health Organization
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	8,268
Start date	13 May 2017
Primary completion	15 January 2020
Estimated completion	15 January 2020
Sites	7 locations across Pakistan, Mali, Malawi, Bangladesh, Kenya, Tanzania, India

Drugs / interventions tested

• Azithromycin (azithromycin) — full drug profile →
• Placebo

Conditions studied

• Diarrhea — all drugs for Diarrhea →

Sponsor

World Health Organization

Who can join

Adults 2 Months to 23 Months, any sex, with Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the 90 days following an episode of acute diarrhoea appear at least as high as mortality that occurs during the acute episode. The long-term benefits of antibiotic administration may result from direct antimicrobial effects on pathogens or from other incompletely understood mechanisms including improved nutrition, alterations in immune tolerance or improved enteric function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children with severe disease may offer the opportunity to significantly reduce diarrhoea associated deaths in the 180 days following presentation for acute diarrhoea and may also improve growth.

The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered in a specific, targeted fashion to young children (\< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study will evaluate the ability of the intervention to reduce mortality within 180 days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of quantitative molecular diagnostic methods to assess the aetiology, burden, and clinical characteristics of diarrhoea in children in low-resource settings: a reanalysis of the MAL-ED cohort study.
   Platts-Mills JA, Liu J, Rogawski ET, Kabir F, et al · · 2018 · cited 308× · PMID 30287127 · DOI 10.1016/s2214-109x(18)30349-8
2. The global problem of childhood diarrhoeal diseases: emerging strategies in prevention and management.
   Mokomane M, Kasvosve I, de Melo E, Pernica JM, et al · · 2018 · cited 136× · PMID 29344358 · DOI 10.1177/2049936117744429
3. The effect of acute malnutrition on enteric pathogens, moderate-to-severe diarrhoea, and associated mortality in the Global Enteric Multicenter Study cohort: a post-hoc analysis.
   Tickell KD, Sharmin R, Deichsel EL, Lamberti LM, et al · · 2020 · cited 56× · PMID 31981554 · DOI 10.1016/s2214-109x(19)30498-x
4. Adverse events in people taking macrolide antibiotics versus placebo for any indication.
   Hansen MP, Scott AM, McCullough A, Thorning S, et al · · 2019 · cited 53× · PMID 30656650 · DOI 10.1002/14651858.cd011825.pub2
5. A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol.
   Sié A, Ouattara M, Bountogo M, Bagagnan C, et al · · 2019 · cited 34× · PMID 31801563 · DOI 10.1186/s13063-019-3855-9
6. Effect of 3 Days of Oral Azithromycin on Young Children With Acute Diarrhea in Low-Resource Settings: A Randomized Clinical Trial.
   Antibiotics for Children With Diarrhea (ABCD) Study Group, Ahmed T, Chisti MJ, Rahman MW, et al · · 2021 · cited 31× · PMID 34913980 · DOI 10.1001/jamanetworkopen.2021.36726
7. Azithromycin for Bacterial Watery Diarrhea: A Reanalysis of the AntiBiotics for Children With Severe Diarrhea (ABCD) Trial Incorporating Molecular Diagnostics.
   Pavlinac PB, Platts-Mills JA, Liu J, Atlas HE, et al · · 2024 · cited 23× · PMID 37405406 · DOI 10.1093/infdis/jiad252
8. Mass azithromycin administration: considerations in an increasingly resistant world.
   Hooda Y, Tanmoy AM, Sajib MSI, Saha S. · · 2020 · cited 22× · PMID 32522739 · DOI 10.1136/bmjgh-2020-002446