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ACTIVE NOT RECRUITING
NCT04326478
PHASE2

Single Dose Azithromycin to Prevent Cholera in Children

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

This study aims to determine whether single-dose azithromycin is effective in preventing cholera in children who are at extremely high risk of infection. The study will also determine the effect of this intervention on the development of antibiotic resistant bacteria. The results will inform future strategies to prevent cholera in children, and improve overall understanding of the impact of azithromycin on antibiotic resistance.

Official title: Azithromycin Prophylaxis in Child Contacts of Cholera Patients: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Year - 15 Years

Study Type

INTERVENTIONAL

Enrollment

920

Start Date

2021-10-31

Completion Date

2026-05-31

Last Updated

2025-07-04

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Azithromycin

Enrolled children in the intervention arm of this study will receive a single weight-based dose of azithromycin (20 mg/kg, to a maximum dose of 1 gram) administered by a trained study nurse within 12 hours of a member of their household testing positive for cholera.

BIOLOGICAL

Placebo

Enrolled children in the placebo arm of this study will receive a single dose of non-antibiotic placebo administered by a trained study nurse within 12 hours of a member of their household testing positive for cholera.

Locations (1)

icddr,b Dhaka hospital

Dhaka, Bangladesh