Kebele Elimination of Trachoma for Ocular Health

Trachoma Clinical Trial

— KETFO  

Official title:

Kebele Elimination of Trachoma for Ocular Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03335072
• Other study ID #: 17-22201
• Secondary ID: 1UG1EY028088
• Status: Recruiting
• Phase: Phase 4
• Start date: February 7, 2022
• Est. completion date: March 1, 2028

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Tom M Lietman, MD
• Phone: 415-502-2662
• Email: Tom.Lietman[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320000
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Trachoma

Intervention

Drug:
• Azithromycin
Mass Drug Administration

Locations

Country	Name	City	State
Ethiopia	Eyu-Ethiopia	Bahir Dar
United States	UCSF Proctor Foundation	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Bahir Dar University, Eyu-Ethiopia, National Eye Institute (NEI)

Countries where clinical trial is conducted

United States,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular chlamydia measured in a population based age-stratified sample of the entire community	Assessed by PCR	36 months
Secondary	Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia	Assessed by PCR	36 months
Secondary	Conjunctival inflammation	Assessed from conjunctival photography	36 months
Secondary	Seropositivity to C. trachomatis antibodies CT694 and Pgp3	Assessed via ELISA on elute from dried blood spots	36 months