TrachomaPhase 4ARRETNCT06289647
Azithromycin Reduction to Reach Elimination of Trachoma B
A Phase 4 study testing Azithromycin in people with Trachoma, run by University of California, San Francisco at 1 site in Democratic Republic of the Congo.
Trial summary
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. Read more about this study
- Who is it for?
- Ages 1 month to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Trachoma
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Oct 2024to 31 Aug 2029
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provision of appropriate informed consent
- Stated willingness to comply with all study procedures
- Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Who cannot join
- Does not consent to participation
- Unwilling to comply with all study procedures
- Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
University of California, San Francisco
Kindu, Maniema Province
About this study
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.
- Conditions
- Trachoma
- Being tested
- Azithromycin
- Medical subject headings
- Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin Continuation | Active comparator | 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). Receives: Drug: Azithromycin |
| Azithromycin Discontinuation | No intervention | In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular chlamydia measured in a population-based sample of 0-9 year-old children
Assessed by PCR.
Measured: 36 months
Secondary outcomes (2)
Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia
Assessed by PCR.
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study startOct 2024 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Why it stopped: Study withdrawn (no participants enrolled) due to resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrachomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Catherine Oldenburg, ScD, MPH, Principal investigator, University of California, San FranciscoThomas Lietman, MD, Principal investigator, University of California, San FranciscoElodie Lebas, RN, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289647
- Sponsor's protocol ID
- 19-28923B
- Other IDs
- 5UG1EY030833
- Acronym
- ARRET
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Reduction to Reach Elimination of Trachoma B
- ClinicalTrials.gov ID
- NCT06289647
- Acronym / sponsor ID
- ARRET / 19-28923B
- Conditions
- Trachoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn (no participants enrolled) due to resources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), National Eye Institute (NEI)
- Study start
- Oct 2024 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin Continuation | Active comparator | Drug: AzithromycinIn 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). |
| Azithromycin Discontinuation | No intervention | –In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. |
Who may qualify
- Ages
- 1 month to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Provision of appropriate informed consent
- Stated willingness to comply with all study procedures
- Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Key exclusion criteria (3 listed)
- Does not consent to participation
- Unwilling to comply with all study procedures
- Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinIn 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. | Drug | Azithromycin Continuation |
Primary outcome
Ocular chlamydia measured in a population-based sample of 0-9 year-old children
Time frame: 36 months
Assessed by PCR.
2 secondary outcomes
Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia
Time frame: 36 months
Conjunctival inflammation
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Trachoma
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
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The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
Active Trachoma
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Active, not recruitingPhase 4
Kebele Elimination of Trachoma for Ocular Health
Trachoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Oldenburg, ScD, MPH principal investigator
University of California, San Francisco
Thomas Lietman, MD principal investigator
University of California, San Francisco
Elodie Lebas, RN study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin in people with Trachoma, run by University of California, San Francisco at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular chlamydia measured in a population-based sample of 0-9 year-old children (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.