Kebele Elimination of Trachoma for Ocular Health

Phase 4

Recruiting

• Conditions: Trachoma
• Interventions: Drug: Azithromycin

• Registration Number: NCT03335072
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Study Start: 2022-02-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2027-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WHO-recommended	Azithromycin	Annual mass azithromycin distribution of all residents
TI-based core group	Azithromycin	Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group
PCR infection-based core group	Azithromycin	Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.
Age-based core group	Azithromycin	Annual mass azithromycin treatment of everyone plus quarterly treatment of children

Primary Outcome Measures

Name	Time	Method
Ocular chlamydia measured in a population based age-stratified sample of the entire community	36 months	Assessed by PCR

Secondary Outcome Measures

Name	Time	Method
Seropositivity to C. trachomatis antibodies CT694 and Pgp3	36 months	Assessed via ELISA on elute from dried blood spots
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia	36 months	Assessed by PCR
Conjunctival inflammation	36 months	Assessed from conjunctival photography

Trial Locations

Locations (2)

UCSF Proctor Foundation; 🇺🇸 San Francisco, California, United States

Eyu-Ethiopia; 🇪🇹 Bahir Dar, Ethiopia