Azithromycin Reduction to Reach Elimination of Trachoma (ARRET)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 100000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Catherine Oldenburg, ScD, MPH; Phone Number: (415) 502-8843; Email: catherine.oldenburg@ucsf.edu
• Study Contact Backup: Name: Aimée Kimfuema, MPH; Phone Number: 4155022662; Email: mponda.kimfuema@ucsf.edu

Study Locations

• Niger
  • Niamey, Niger
    • Recruiting
    • Programme National de Santé Oculaire (PNSO)
    • Contact: Abdou Amza, MD; Phone Number: +227 96967009; Email: dr.amzaabdou@gmail.com
    • Principal Investigator: Abdou Amza, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• 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.	36 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Eye Institute (NEI); Programme National de Santé Oculaire (PNSO)
• Investigators: Study Director: Elodie Lebas, RN, University of California, San Francisco; Principal Investigator: Tom Lietman, MD, University of California, San Francisco; Principal Investigator: Catherine Oldenburg, ScD, MPH, University of California, San Francisco

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Chlamydiaceae Infections; Eye Infections, Bacterial; Eye Infections; Chlamydia Infections; Conjunctivitis, Bacterial; Trachoma; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: 19-28923; 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