Azithromycin Reduction to Reach Elimination of Trachoma B

Trachoma Clinical Trial

— ARRET  

Official title:

Azithromycin Reduction to Reach Elimination of Trachoma B

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
• 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
• 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

Related Conditions & MeSH terms

• Trachoma

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