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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03335072
Other study ID # 17-22201
Secondary ID 1UG1EY028088
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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