Preventing cholera in children with a single dose of azithromycin
Azithromycin Prophylaxis in Child Contacts of Cholera Patients: A Randomized Controlled Trial
This study tests if giving a single dose of azithromycin can help prevent cholera in children who are at high risk of getting the disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 920 (estimated) |
| Ages | 1 Year to 15 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT04326478 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a single dose of azithromycin in preventing cholera among children at high risk of infection. It aims to assess not only the prevention of cholera but also the impact of this antibiotic on the development of antibiotic-resistant bacteria. The study is particularly relevant in the context of ongoing cholera epidemics, such as the one in Yemen, where children are disproportionately affected. By evaluating the outcomes, the research seeks to inform future strategies for cholera prevention and antibiotic use in vulnerable populations.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 15 years who have shared cooking facilities with a household member confirmed to have cholera.
Not a fit: Patients who are currently participating in other drug trials or have known allergies to azithromycin will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of cholera in children, potentially saving lives and improving child health outcomes.
How similar studies have performed: Other studies have indicated the potential effectiveness of antibiotic prophylaxis in cholera prevention, but this specific approach with azithromycin is novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka
- icddr,b Dhaka hospital — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Jason B Harris, MD, MPH — Massachusetts General Hospital
- Study coordinator: Jason B Harris, MD, MPH
- Email: jbharris@mgh.harvard.edu
- Phone: 617-643-5664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.