Azithromycin Reduction to Reach Elimination of Trachoma B

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2029-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Trachoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Double (Investigator, Outcomes Assessor)

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type 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.

Azithromycin Discontinuation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes