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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	18 March 2024
Main ID:	NCT03335072
Date of registration:	03/11/2017
Prospective Registration:	Yes
Primary sponsor:	University of California, San Francisco
Public title:	Kebele Elimination of Trachoma for Ocular Health KETFO
Scientific title:	Kebele Elimination of Trachoma for Ocular Health
Date of first enrolment:	February 7, 2022
Target sample size:	320000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03335072
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Ethiopia	United States

Contacts

Name:	Tom M Lietman, MD
Address:
Telephone:
Email:
Affiliation:	University of California, San Francisco

Name:	Hadley Burroughs, MSPH
Address:
Telephone:
Email:
Affiliation:	University of California, San Francisco

Name:	Esmael Habtamu Ali, PhD
Address:
Telephone:
Email:
Affiliation:

Name:	Tom M Lietman, MD
Address:
Telephone:	415-502-2662
Email:	Tom.Lietman@ucsf.edu
Affiliation:

Key inclusion & exclusion criteria

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.

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Trachoma

Intervention(s)

Drug: Azithromycin

Primary Outcome(s)

Ocular chlamydia measured in a population based age-stratified sample of the entire community [Time Frame: 36 months]

Secondary Outcome(s)

Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia [Time Frame: 36 months]

Seropositivity to C. trachomatis antibodies CT694 and Pgp3 [Time Frame: 36 months]

Conjunctival inflammation [Time Frame: 36 months]

Secondary ID(s)

17-22201

1UG1EY028088

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eyu-Ethiopia

Bahir Dar University

National Eye Institute (NEI)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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