Azithromycin Reduction to Reach Elimination of Trachoma B (ARRET)

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 Overview

• Status: Withdrawn
• Conditions: Trachoma
• Intervention / Treatment: Drug: Azithromycin

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Democratic Republic of the Congo
  • Maniema Province
    • Kindu, Maniema Province, Democratic Republic of the Congo
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Azithromycin Continuation; 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 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.
No Intervention: Azithromycin Discontinuation; In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular chlamydia measured in a population-based sample of 0-9 year-old children	Assessed by PCR.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia	Assessed by PCR.	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	36 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Eye Institute (NEI); Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
• Investigators: Principal Investigator: Thomas Lietman, MD, University of California, San Francisco; Study Director: Elodie Lebas, RN, University of California, San Francisco; Principal Investigator: Catherine Oldenburg, ScD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Corneal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Conjunctivitis; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Chlamydiaceae Infections; Conjunctivitis, Bacterial; Chlamydia Infections; Trachoma; Organic Chemicals; Macrolides; Lactones; Erythromycin; Polyketides; Azithromycin
• Other Study ID Numbers: 19-28923B; 5UG1EY030833 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes