Phase 4
N=3,931
Azithromycin Reduction to Reach Elimination of Trachoma
Trachoma
Bottom Line
View on ClinicalTrials.gov: NCT04185402 ↗Enrolled (actual)
3,931
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Ocular Chlamydia Measured in a Population-based Sample of 0-9 Year-old Children — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azithromycin (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Chlamydia Measured in a Population-based Sample of 0-9 Year-old Children |
0; 0 | — |
| SECONDARY Infectious Load of Chlamydia Among 0-9 Year-old Children Infected With Ocular Chlamydia |
0; 0 | — |
| SECONDARY Conjunctival Inflammation |
6; 4 | — |
Summary
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.
Eligibility Criteria
Inclusion Criteria
- Provision of appropriate informed consent
- Stated willingness to comply with all study procedures
- Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Exclusion Criteria
- Does not consent to participation
- Unwilling to comply with all study procedures
- Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Data sourced from ClinicalTrials.gov (NCT04185402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.