YCFM (Youth Correctional Facilities Males)

Treatment Failure and Associated Predictors Following Azithromycin Treatment for Urogenital Chlamydial Infection in Males in Youth Correctional Facilities

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.

Study Overview

• Status: Completed
• Conditions: Chlamydial Infection
• Intervention / Treatment: Drug: Azithromycin

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-segregated YCFs. 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. Males age 12 to 21 years in good health (based on vital signs and provider's clinical evaluation documented in medical records) who are residing in long-term gender-segregated (not co-ed) YCFs (usual stay > 3 weeks) and who are identified as chlamydia-infected comprise the study population. The anticipated enrollment is 446 males 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; in essence, this study will assess the frequency of chlamydia treatment failure to azithromycin at the Day 28 follow-up visit (Visit 2) in males with urethral symptoms compared to males without urethral symptoms. The secondary objective is to evaluate the association of laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.) to chlamydia treatment failure in males after azithromycin treatment.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90031
      • Los Angeles County Department of Health Services - Juvenile Court Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Azithromycin; Azithromycin 1 gm PO single dose given as directly observed	Drug: Azithromycin; Azithromycin 1 gm PO single dose given as directly observed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms	Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.	Day 28-follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment	Odds ratios for the outcome of treatment failure calculated for laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.). Note that samples were not run for OmpA genotype.	Day 28-follow-up visit

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2017
• Primary Completion (ACTUAL): September 17, 2018
• Study Completion (ACTUAL): September 17, 2018

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Chlamydia; Azithromycin; Youth; Symptoms; Correctional; Facilities; Urethral; Urogenital
• Additional Relevant MeSH Terms: Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Infections; Chlamydia Infections; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: 16-0002; HHSN272201300012I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No