Elimination of trachoma through targeted azithromycin distribution
Kebele Elimination of Trachoma for Ocular Health
This study is testing if giving azithromycin more frequently and in a targeted way can help eliminate trachoma in communities compared to the usual once-a-year approach.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 320000 (estimated) |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT03335072 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an intensive, targeted distribution strategy of azithromycin for eliminating trachoma at the kebele level, compared to the standard annual distribution recommended by the WHO. The study will randomize 80 kebeles, each consisting of approximately 15 villages and 4,000 residents, into four different treatment arms. These arms include variations of annual and quarterly treatments targeting children based on age, positive chlamydial PCR tests, or signs of conjunctival inflammation. The primary outcome will assess ocular chlamydia prevalence over 36 months, with secondary outcomes focusing on bacterial load and clinically active trachoma prevalence.
Who should consider this trial
Good fit: Ideal candidates for this study include all residents of the kebeles participating in the trial, particularly children aged 0-9 years.
Not a fit: Patients who do not consent to participate in the trial will not benefit from the interventions.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the prevalence of trachoma and improve ocular health in affected communities.
How similar studies have performed: Previous studies have shown success with mass drug administration strategies for trachoma, but this targeted approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines. Exclusion Criteria: * Those who do not consent.
Where this trial is running
San Francisco, California and 1 other locations
- UCSF Proctor Foundation — San Francisco, California, United States (Active_not_recruiting)
- Eyu-Ethiopia — Bahir Dar, Ethiopia (Recruiting)
Study contacts
- Principal investigator: Tom M Lietman, MD — University of California, San Francisco
- Study coordinator: Tom M Lietman, MD
- Email: Tom.Lietman@ucsf.edu
- Phone: 415-502-2662
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.