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.
Trial summary
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger. Read more about this study
- 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
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Programme National de Santé Oculaire (PNSO), National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Catherine Oldenburg, ScD, MPH, Principal investigator, University of California, San FranciscoTom 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
- 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