Azithromycin Reduction to Reach Elimination of Trachoma B

NCT06289647 | Withdrawn Phase 4 DMC FDA Drug

• 2 other identifiers: 19-28923B5UG1EY030833
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trachoma

Outcome Measures

Primary Outcomes (1)

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

  Assessed by PCR.

  36 months

Secondary Outcomes (2)

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

  36 months

• Conjunctival inflammation

  36 months

Study Arms (2)

Azithromycin Continuation

ACTIVE COMPARATOR

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

Azithromycin Discontinuation

NO INTERVENTION

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

Interventions

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.

Azithromycin Continuation

Eligibility Criteria

• Age: 1 Month - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• University of California, San Francisco: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of California, San Francisco

Kindu, Maniema Province, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Trachoma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Catherine Oldenburg, ScD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Thomas Lietman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Elodie Lebas, RN

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 4, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)