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Kebele Elimination of Trachoma for Ocular Health (KETFO)

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ClinicalTrials.gov Identifier: NCT03335072
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : May 5, 2020
Sponsor:
Collaborators:
National Eye Institute (NEI)
The Carter Center
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date May 5, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
Ocular chlamydia measured in a population based age-stratified sample of the entire community [ Time Frame: 36 months ]
Assessed by PCR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia [ Time Frame: 36 months ]
    Assessed by PCR
  • Conjunctival inflammation [ Time Frame: 36 months ]
    Assessed from conjunctival photography
  • Seropositivity to C. trachomatis antibodies CT694 and Pgp3 [ Time Frame: 36 months ]
    Assessed via ELISA on elute from dried blood spots
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia [ Time Frame: 36 months ]
    Assessed by PCR
  • Conjunctival inflammation [ Time Frame: 36 months ]
    Assessed from conjunctival photography
  • Clinically active trachoma [ Time Frame: 36 months ]
    Measured by exam
  • Nasopharyngeal pneumococcal macrolide resistance [ Time Frame: 36 months ]
    Assessed by PCR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kebele Elimination of Trachoma for Ocular Health
Official Title  ICMJE Kebele Elimination of Trachoma for Ocular Health
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trachoma
Intervention  ICMJE Drug: Azithromycin
Mass Drug Administration
Other Name: Zithromax
Study Arms  ICMJE
  • Active Comparator: WHO-recommended
    Annual mass azithromycin distribution of all residents
    Intervention: Drug: Azithromycin
  • Experimental: Age-based core group
    Annual mass azithromycin treatment of everyone plus quarterly treatment of children
    Intervention: Drug: Azithromycin
  • 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.
    Intervention: Drug: Azithromycin
  • 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
    Intervention: Drug: Azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
320000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tom M Lietman, MD 415-502-2662 Tom.Lietman@ucsf.edu
Contact: Ariana F Austin, MS 415-502-0275 Ariana.Austin@ucsf.edu
Listed Location Countries  ICMJE Ethiopia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335072
Other Study ID Numbers  ICMJE 17-22201
1UG1EY028088 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • National Eye Institute (NEI)
  • The Carter Center
Investigators  ICMJE
Principal Investigator: Tom M Lietman, MD University of California, San Francisco
Study Director: Ariana F Austin, MS University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP