Single Dose Azithromycin to Prevent Cholera in Children

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh
• Treatments: Azithromycin

Criteria

Inclusion criteria:

• Shared cooking facilities for the prior three days with a household member who tested positive for cholera

• Age 1 to 15 years

• A parent or guardian available to provide informed consent

• Intention to remain enrolled in the study for 6 months

Exclusion criteria:

• Participation in any other drug, device, or vaccine trial at present or within the past 30 days

• Known or suspected hypersensitivity to azithromycin or other macrolide antibiotics