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Kebele Elimination of Trachoma for Ocular Health

Kebele Elimination of Trachoma for Ocular Health

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03335072
Acronym
KETFO
Enrollment
320000
Registered
2017-11-07
Start date
2022-02-07
Completion date
2028-03-01
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trachoma

Keywords

Azithromycin, Mass Drug Administration, Antibiotic Resistance

Brief summary

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.

Detailed description

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.

Interventions

DRUGAzithromycin

Mass Drug Administration

Sponsors

National Eye Institute (NEI)
CollaboratorNIH
Eyu-Ethiopia
CollaboratorUNKNOWN
Bahir Dar University
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ocular chlamydia measured in a population based age-stratified sample of the entire community36 monthsAssessed by PCR

Secondary

MeasureTime frameDescription
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia36 monthsAssessed by PCR
Conjunctival inflammation36 monthsAssessed from conjunctival photography

Countries

Ethiopia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026