TrachomaPhase 4ARRETNCT04185402

Azithromycin Reduction to Reach Elimination of Trachoma

A Phase 4 study testing Azithromycin in people with Trachoma, run by University of California, San Francisco at 1 site in Niger.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 month and olderHealthy 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: 3,931 participants
Where: 1 siteNiger
Study dates: 29 May 2021to 18 Dec 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Niger1 site

Programme National de Santé Oculaire (PNSO)
Niamey

Other trials in Niger

About this study

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.

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 groups in NCT04185402
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.
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 202118 Dec 2024

First posted4 Dec 2019
Study start29 May 2021
Primary completion18 Dec 2024
Study completion18 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 3,931 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04185402
Sponsor's protocol ID: 19-28923
Other IDs: 5UG1EY030833
Acronym: ARRET
Status last verified: Mar 2026
First submitted: 2 Dec 2019
Last updated: 25 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Amza A, Kadri B, Nassirou B, Arzika AM, Austin A, Nyatigo F, Lebas E, Arnold BF, Lietman TM, Oldenburg CE. Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma. BMC Ophthalmol. 2021 Jan 6;21(1):15. doi: 10.1186/s12886-020-01776-4.
PubMed 33407263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Not yet recruiting
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

All Trachoma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Azithromycin Reduction to Reach Elimination of Trachoma
ClinicalTrials.gov ID: NCT04185402
Acronym / sponsor ID: ARRET / 19-28923
Conditions: Trachoma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,931 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Programme National de Santé Oculaire (PNSO), National Eye Institute (NEI)
Study start: 29 May 2021 (actual)
Primary completion: 18 Dec 2024 (actual)
Study completion: 18 Dec 2024 (actual)
First posted: 4 Dec 2019 (actual)
Results: Posted 25 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

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

Results posted to the registry on 25 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin Continuation	1,950	1,950
Azithromycin Discontinuation	1,981	1,981

Primary outcome: Ocular Chlamydia Measured in a Population-based Sample of 0-9 Year-old Children

Time frame: 36 months. Count of participants. Unit: Participants

Measure	Azithromycin Continuation n = 1993	Azithromycin Discontinuation n = 1978
Value	0	0

Population analysed: This is a cluster-randomized trial wit cross-sectional data collection at baseline and endline. Participant Flow reflects counts of clusters and enrolled children, not the analytic dataset. The number analyzed includes all eligible individuals captured in the cross-sectional villages, which may exceed the number 'Started' in Participant Flow.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin Continuation	0 of 1,999 (0%)	0 of 1,999 (0%)	0 of 1,999
Azithromycin Discontinuation	0 of 1,981 (0%)	0 of 1,981 (0%)	0 of 1,981

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33407263Amza A, Kadri B, Nassirou B, Arzika AM, Austin A, Nyatigo F, Lebas E, Arnold BF, Lietman TM, Oldenburg CE. Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma. BMC Ophthalmol. 2021 Jan 6;21(1):15. doi: 10.1186/s12886-020-01776-4.
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
Not yet recruiting
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

Tom 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 Niger.

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: finished, as of the sponsor's last update on 25 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 Niger. 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?

Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

On the ClinicalTrials.gov record for NCT04185402, which also lists 1 linked publication.

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 25 Mar 2026.