Antibiotics for Children With Severe Diarrhoea

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

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Center for Public Health Kinetics

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Centre pour le developpement des vaccines, Mali

  collaborator UNKNOWN

• University of Maryland, College Park

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• Muhimbili University of Health and Allied Sciences

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• World Health Organization

  lead OTHER

Principal Investigators

• Rajiv Bahl · World Health Organization

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

23 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-13

Primary Completion

2020-01-15

Completion

2020-01-15

Countries

• Bangladesh
• India
• Kenya
• Malawi
• Mali
• Pakistan
• Tanzania

Study Locations