Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03335072

Kebele Elimination of Trachoma for Ocular Health

The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eyu-Ethiopia, Bahir Dar, Ethiopia

Loading trial locations.

About this study

The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines.

Exclusion criteria

  • Those who do not consent.

Treatment and study plan

Azithromycin

Drug

Mass Drug Administration

Other names: Zithromax

Primary outcomes

  1. Ocular chlamydia measured in a population based age-stratified sample of the entire community

    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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bahir Dar University
  • Eyu-Ethiopia
  • National Eye Institute (NEI)

Registry information

Acronym: KETFO

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Nov 7, 2017
Registry last updated
Oct 23, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.