NCT03130114

Antibiotics for Children With Severe Diarrhoea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,268 (actual)
• Sponsor: World Health Organization · Academic / Other
• Sex: All
• Age: 2 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Azithromycin	Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 10 mg (0.35 ml) / kg of azithromycin syrup per day, for three days
OTHER	Placebo	Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 0.25 ml / kg of placebo drug syrup per day, for three days

Timeline

• Start date: 2017-05-13
• Primary completion: 2020-01-15
• Completion: 2020-01-15
• First posted: 2017-04-26
• Last updated: 2020-05-19

Locations

7 sites across 7 countries: Bangladesh, India, Kenya, Malawi, Mali, Pakistan, Tanzania