TrachomaPhase 4KETFONCT03335072
Kebele Elimination of Trachoma for Ocular Health
A Phase 4 study testing Azithromycin in people with Trachoma, run by University of California, San Francisco at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trachoma
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Feb 2022to 1 Mar 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines.
Who cannot join
- Those who do not consent.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
UCSF Proctor Foundation
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Trachoma
- Being tested
- Azithromycin
- Keywords
- Azithromycin, Mass Drug Administration, Antibiotic Resistance
- Medical subject headings
- Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
Mass Drug Administration
| Study group | Role | What they receive |
|---|---|---|
| WHO-recommended | Active comparator | Annual mass azithromycin distribution of all residents Receives: Drug: Azithromycin |
| Age-based core group | Experimental | Annual mass azithromycin treatment of everyone plus quarterly treatment of children Receives: Drug: Azithromycin |
| PCR infection-based core group | Experimental | Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group. Receives: Drug: Azithromycin |
| TI-based core group | Experimental | Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular chlamydia measured in a population based age-stratified sample of the entire community
Assessed by PCR
Measured: 36 months
Secondary outcomes (2)
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia
Assessed by PCR
Measured: 36 months
Conjunctival inflammation
Assessed from conjunctival photography
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start7 Feb 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrachomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Eyu-Ethiopia, Bahir Dar University
- Responsible party
- Sponsor
- Investigators
- Tom M Lietman, MD, Principal investigator, University of California, San FranciscoHadley Burroughs, MSPH, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335072
- Sponsor's protocol ID
- 17-22201
- Other IDs
- 1UG1EY028088
- Acronym
- KETFO
- Status last verified
- Oct 2025
- First submitted
- 3 Nov 2017
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No