Status:
COMPLETED
YCFM (Youth Correctional Facilities Males)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chlamydial Infection
Eligibility:
MALE
12-21 years
Phase:
PHASE2
Brief Summary
The proposed study is a single center (with multiple long-term YCFs) treatment trial of the CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is designed primarily...
Detailed Description
The proposed study is a single center (with multiple long-term YCFs) treatment trial of the CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males residing in long-term gender-segr...
Eligibility Criteria
Inclusion
- Male between the ages of 12 and 21 years 2.Residing in a long-term gender-segregated (no co-ed) YCF 3.Diagnosed with urogenital chlamydia as determined by a screening C. trachomatis NAAT 4.Anticipated length of stay at the YCF at the time of enrollment is at least 28 days 5.Willingness to provide written consent 6.Willingness to comply with study procedures
Exclusion
- Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae NAAT 2.Clinical diagnosis of epididymitis based on review of medical records 3.Known allergy to azithromycin, erythromycin, any macrolide or ketolide drug 4.History of liver problems due to use of azithromycin 5.Having received antimicrobial therapy with activity against C. trachomatis within 21 days of the positive chlamydia screening NAAT or in the interval between the positive screening NAAT and study enrollment 6.Any concomitant infection, which requires antimicrobial therapy with activity against C. trachomatis 7.Previously enrolled in this study 8.Unable to swallow pills 9.Other exclusion criteria, per clinician judgment, that prohibits subject from enrolling in study
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03249935
Start Date
August 24 2017
End Date
September 17 2018
Last Update
October 28 2019
Active Locations (1)
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1
Los Angeles County Department of Health Services - Juvenile Court Health Services
Los Angeles, California, United States, 90031