Phase 2 N=100 Treatment

YCFM (Youth Correctional Facilities Males)

Chlamydial Infection

Bottom Line

View on ClinicalTrials.gov: NCT03249935 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms — 1; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Azithromycin (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: Male
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms	1; 3	—
SECONDARY Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment	4	0.656

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 to determine the frequency of chlamydia treatment failure following azithromycin in males who do versus do not have urethral symptoms of urethral discharge and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old, with subject participation duration of 28 days and study duration of 4 years. The primary objective of the study is to assess the microbiological efficacy of azithromycin in uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms in YCFs.

Eligibility Criteria

Inclusion Criteria

1.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 Criteria

1.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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03249935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.