A Phase 4 interventional study of Azithromycin in Trachoma, sponsored by University of California, San Francisco. Completed at 1 site in Niger. Open to participants aged 1 Month and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.
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 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.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 3,931 is above the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 36 months
| Milestone | Azithromycin Continuation | Azithromycin Discontinuation |
|---|---|---|
| Started | 1950 | 1981 |
| Completed | 1950 | 1981 |
| Not completed | 0 | 0 |
| Milestone | Azithromycin Continuation | Azithromycin Discontinuation |
|---|---|---|
| Started | 2009 | 1990 |
| Completed | 2009 | 1990 |
| Not completed | 0 | 0 |
Assessed by PCR
| Participants | Azithromycin Continuation | Azithromycin Discontinuation |
|---|---|---|
| Ocular Chlamydia Measured in a Population-based Sample of 0-9 Year-old Children | 0 | 0 |
Assessed by PCR
| copies/mL | Azithromycin Continuation | Azithromycin Discontinuation |
|---|---|---|
| Infectious Load of Chlamydia Among 0-9 Year-old Children Infected With Ocular Chlamydia | 0 ± 0 | 0 ± 0 |
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.
| Participants | Azithromycin Continuation | Azithromycin Discontinuation |
|---|---|---|
| Conjunctival Inflammation | 6 | 4 |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin Continuation | 0/1,999 (0%) | 0/1,999 (0%) | 0/1,999 (0%) |
| Azithromycin Discontinuation | 0/1,981 (0%) | 0/1,981 (0%) | 0/1,981 (0%) |
| Age, Categorical(Participants) | Azithromycin Continuation | Azithromycin Discontinuation | Total |
|---|---|---|---|
| <=18 years | 1950 | 1981 | 3931 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(year) | Azithromycin Continuation | Azithromycin Discontinuation | Total |
|---|---|---|---|
| Mean | 4.0 ± 2.6 | 4.0 ± 2.5 | 4.0 ± 2.6 |
| Sex: Female, Male(Participants) | Azithromycin Continuation | Azithromycin Discontinuation | Total |
|---|---|---|---|
| Female | 958 | 966 | 1924 |
| Male | 992 | 1015 | 2007 |
| Race (NIH/OMB)(Participants) | Azithromycin Continuation | Azithromycin Discontinuation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1950 | 1981 | 3931 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Azithromycin Continuation | Azithromycin Discontinuation | Total |
|---|---|---|---|
| Niger | 1950 | 1981 | 3931 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2021 to primary completion in Dec 2024, 42 months.
Results were first posted in Mar 2026, 1 year 3 months after primary completion.
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Studies of the drug tested here: Azithromycin
University of California, San Francisco →