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.
Phase:
Phase 3
Details
Lead Sponsor:
Per Ashorn World Health Organization
Collaborators:
Aga Khan University Boston Children's Hospital Boston Children’s Hospital Center for Public Health Kinetics Centre pour le developpement des vaccines, Mali International Centre for Diarrhoeal Disease Research, Bangladesh Kenya Medical Research Institute Malawi-Liverpool-Wellcome Trust Clinical Research Programme Muhimbili University of Health and Allied Sciences University of Liverpool University of Maryland University of Maryland, College Park University of Washington