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Azithromycin Reduction to Reach Elimination of Trachoma (ARRET)

Primary Purpose

Trachoma

Status

Recruiting

Phase

Phase 4

Locations

Niger

Study Type

Interventional

Intervention

Azithromycin

About this trial

This is an interventional treatment trial for Trachoma

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Programme National de Santé Oculaire (PNSO)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Azithromycin Continuation

Azithromycin Discontinuation

Arm Description

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).

In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.

Outcomes

Primary Outcome Measures

Ocular chlamydia measured in a population-based sample of 0-9 year-old children

Assessed by PCR

Secondary Outcome Measures

Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia

Assessed by PCR

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.

Full Information

NCT ID

NCT04185402

First Posted

December 2, 2019

Last Updated

August 15, 2023

Sponsor

University of California, San Francisco

Collaborators

Programme National de Santé Oculaire (PNSO)

1. Study Identification

Unique Protocol Identification Number

NCT04185402

Brief Title

Azithromycin Reduction to Reach Elimination of Trachoma

Acronym

ARRET

Official Title

Azithromycin Reduction to Reach Elimination of Trachoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 29, 2021 (Actual)

Primary Completion Date

October 31, 2026 (Anticipated)

Study Completion Date

January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Programme National de Santé Oculaire (PNSO)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trachoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Azithromycin Continuation

Arm Type

Active Comparator

Arm Description

Arm Title

Azithromycin Discontinuation

Arm Type

No Intervention

Arm Description

In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ocular chlamydia measured in a population-based sample of 0-9 year-old children

Description

Assessed by PCR

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia

Description

Assessed by PCR

Time Frame

36 months

Title

Conjunctival inflammation

Description

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.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Oldenburg, ScD, MPH

Phone

(415) 502-8843

catherine.oldenburg@ucsf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Aimée Kimfuema, MPH

Phone

4155022662

mponda.kimfuema@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine Oldenburg, ScD, MPH

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tom Lietman, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Elodie Lebas, RN

Organizational Affiliation

University of California, San Francisco

Official's Role

Study Director

Facility Information:

Facility Name

Programme National de Santé Oculaire (PNSO)

City

Niamey

Country

Niger

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abdou Amza, MD

Phone

+227 96967009

dr.amzaabdou@gmail.com

First Name & Middle Initial & Last Name & Degree

Abdou Amza, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33407263

Citation

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.

Results Reference

derived

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Azithromycin Reduction to Reach Elimination of Trachoma

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