NCT03335072

Kebele Elimination of Trachoma for Ocular Health

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320,000 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.

Detailed description

The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 months.

Conditions

• Trachoma

Interventions

Type	Name	Description
DRUG	Azithromycin	Mass Drug Administration

Timeline

• Start date: 2022-02-07
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2017-11-07
• Last updated: 2025-10-23

Locations

2 sites across 2 countries: United States, Ethiopia

Regulatory

• FDA-regulated drug study