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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06289647
Other study ID # 19-28923B
Secondary ID 5UG1EY030833
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 28, 2024
Est. completion date August 31, 2029

Study information

Verified date May 2024
Source University of California, San Francisco
Contact Catherine Oldenburg, ScD, MPH
Phone (415) 502-8843
Email catherine.oldenburg@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100000
Est. completion date August 31, 2029
Est. primary completion date August 31, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 9 Years
Eligibility Inclusion Criteria: - Provision of appropriate informed consent - Stated willingness to comply with all study procedures - Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial Exclusion Criteria: - Does not consent to participation - Unwilling to comply with all study procedures - Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.

Locations

Country Name City State
Congo, The Democratic Republic of the University of California, San Francisco Kindu Maniema

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, National Eye Institute (NEI)

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ocular chlamydia measured in a population-based sample of 0-9 year-old children 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. Clinical photographs of the conjunctiva will be assessed by masked graders according to the grading scale described by the WHO Simplified Grading System.
The system includes five signs, each of which can be present or absent:
Trachomatous inflammation - follicular Trachomatous inflammation-intense Trachomatous scarring Trachomatous trichiasis Corneal opacity
36 months
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