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KETFO: Kebele Elimination of Trachoma for Ocular Health

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT03335072
Collaborator
National Eye Institute (NEI) (NIH), Eyu-Ethiopia (Other), Bahir Dar University (Other)
320,000
Enrollment
2
Locations
4
Arms
72.7
Anticipated Duration (Months)
160000
Patients Per Site
2199.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Kebele Elimination of Trachoma for Ocular Health
Actual Study Start Date :
Feb 7, 2022
Anticipated Primary Completion Date :
Mar 1, 2027
Anticipated Study Completion Date :
Mar 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: WHO-recommended

Annual mass azithromycin distribution of all residents

Drug: Azithromycin
Mass Drug Administration
Other Names:
  • Zithromax

    		•
    Experimental: Age-based core group

    Annual mass azithromycin treatment of everyone plus quarterly treatment of children

    Drug: Azithromycin
    Mass Drug Administration
    Other Names:
  • Zithromax

    		•
    Experimental: PCR infection-based core group

    Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.

    Drug: Azithromycin
    Mass Drug Administration
    Other Names:
  • Zithromax

    		•
    Experimental: TI-based core group

    Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group

    Drug: Azithromycin
    Mass Drug Administration
    Other Names:
  • Zithromax

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ocular chlamydia measured in a population based age-stratified sample of the entire community [36 months]

      Assessed by PCR

    Secondary Outcome Measures

    1. Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia [36 months]

      Assessed by PCR

    2. Conjunctival inflammation [36 months]

      Assessed from conjunctival photography

    3. Seropositivity to C. trachomatis antibodies CT694 and Pgp3 [36 months]

      Assessed via ELISA on elute from dried blood spots

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSF Proctor Foundation San Francisco California United States 94143
    2 Eyu-Ethiopia Bahir Dar Ethiopia

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Tom M Lietman, MD, University of California, San Francisco
    • Study Director: Ariana F Austin, MS, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03335072
    Other Study ID Numbers:
    • 17-22201
    • 1UG1EY028088
    First Posted:
    Nov 7, 2017
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University of California, San Francisco
    Azithromycin
    Mass Drug Administration
    Antibiotic Resistance
    Additional relevant MeSH terms:
    Trachoma
    Azithromycin

    Study Results

    No Results Posted as of Feb 24, 2022