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Kebele Elimination of Trachoma for Ocular Health (KETFO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
Trachoma Drug: Azithromycin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022


Arm Intervention/treatment
Active Comparator: WHO-recommended
Annual mass azithromycin distribution of all residents
Drug: Azithromycin
Mass Drug Administration
Other Name: Zithromax

Experimental: Age-based core group
Annual mass azithromycin treatment of everyone plus quarterly treatment of children
Drug: Azithromycin
Mass Drug Administration
Other Name: 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 Name: 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 Name: Zithromax




Primary Outcome Measures :
  1. Ocular chlamydia measured in a population based age-stratified sample of the entire community [ Time Frame: 36 months ]
    Assessed by PCR


Secondary Outcome Measures :
  1. Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia [ Time Frame: 36 months ]
    Assessed by PCR

  2. Conjunctival inflammation [ Time Frame: 36 months ]
    Assessed from conjunctival photography

  3. Seropositivity to C. trachomatis antibodies CT694 and Pgp3 [ Time Frame: 36 months ]
    Assessed via ELISA on elute from dried blood spots



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335072


Contacts
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Contact: Tom M Lietman, MD 415-502-2662 Tom.Lietman@ucsf.edu
Contact: Ariana F Austin, MS 415-502-0275 Ariana.Austin@ucsf.edu

Locations
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United States, California
UCSF Proctor Foundation
San Francisco, California, United States, 94143
Ethiopia
The Carter Center
Addis Ababa, Ethiopia
Contact: Zerihun Tadesse, MD    +251-116-631863    Zerihun.Tadesse@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Eye Institute (NEI)
The Carter Center
Investigators
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Principal Investigator: Tom M Lietman, MD University of California, San Francisco
Study Director: Ariana F Austin, MS University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03335072    
Other Study ID Numbers: 17-22201
1UG1EY028088 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents