A Phase 4 interventional study of Azithromycin in Trachoma, sponsored by University of California, San Francisco. Withdrawn at 1 site in Democratic Republic of the Congo. Open to participants aged 1 Month to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. 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.
Exclusion Criteria:
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. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).
Drug: Azithromycin
In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.
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.
Ocular chlamydia measured in a population-based sample of 0-9 year-old children
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. Clinical photographs of the conjunctiva will be assessed by masked graders according to the grading scale described by the WHO Simplified Grading System. The system includes five signs, each of which can be present or absent: Trachomatous inflammation - follicular Trachomatous inflammation-intense Trachomatous scarring Trachomatous trichiasis Corneal opacity
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco