Status:
ACTIVE_NOT_RECRUITING
Single Dose Azithromycin to Prevent Cholera in Children
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Cholera
Eligibility:
All Genders
1-15 years
Phase:
PHASE2
Brief 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 th...
Detailed Description
Vibrio cholerae causes 3 million cases of cholera and 100,000 deaths annually. An ongoing epidemic in Yemen has caused 1.7 million cases of cholera, with 58% of cholera-related deaths occurring in chi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
920 Patients enrolled
Trial Details
Trial ID
NCT04326478
Start Date
October 31 2021
End Date
May 31 2026
Last Update
July 4 2025
Active Locations (1)
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1
icddr,b Dhaka hospital
Dhaka, Bangladesh