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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
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
December 2, 2019
Last Updated
August 15, 2023
Sponsor
University of California, San Francisco
Collaborators
Programme National de Santé Oculaire (PNSO)
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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
No
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
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).
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
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
Email
catherine.oldenburg@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Aimée Kimfuema, MPH
Phone
4155022662
Email
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
Email
dr.amzaabdou@gmail.com
First Name & Middle Initial & Last Name & Degree
Abdou Amza, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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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