A Phase 4 interventional study of Azithromycin in Trachoma, sponsored by University of California, San Francisco. Active, not recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-10-23.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Annual mass azithromycin distribution of all residents
Drug: Azithromycin
Annual mass azithromycin treatment of everyone plus quarterly treatment of children
Drug: Azithromycin
Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.
Drug: 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
Drug: Azithromycin
Mass Drug Administration
Also known as: Zithromax
Ocular chlamydia measured in a population based age-stratified sample of the entire community
Assessed by PCR
Time frame: 36 months
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia
Assessed by PCR
Time frame: 36 months
Conjunctival inflammation
Assessed from conjunctival photography
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco