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OpenTrials
Completed

NCT Number: NCT04185402

Azithromycin Reduction to Reach Elimination of Trachoma

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.

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Key information

Conditions

Trachoma Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Corneal Diseases Eye Diseases Eye Infections Eye Infections, Bacterial Gram-Negative Bacterial Infections Infections

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Programme National de Santé Oculaire (PNSO)

Niamey, Niger

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

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 outcomes

  1. Ocular Chlamydia Measured in a Population-based Sample of 0-9 Year-old Children

    Time frame: 36 months

    Assessed by PCR

Secondary outcomes

  1. Infectious Load of Chlamydia Among 0-9 Year-old Children Infected With Ocular Chlamydia

    Time frame: 36 months

    Assessed by PCR

  2. Conjunctival Inflammation

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Eye Institute (NEI)
  • Programme National de Santé Oculaire (PNSO)

Registry information

Acronym: ARRET

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2019
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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