NCT04185402

Azithromycin Reduction to Reach Elimination of Trachoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,931 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Accepted

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.

Conditions

• Trachoma

Interventions

Type	Name	Description
DRUG	Azithromycin	In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.

Timeline

• Start date: 2021-05-29
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2019-12-04
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

1 site across 1 country: Niger

Regulatory

• FDA-regulated drug study