YCFM (Youth Correctional Facilities Males)

NCT03249935 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 16-0002HHSN272201300012I
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chlamydial Infection

Keywords

Azithromycin; Chlamydia; Correctional; Facilities; Symptoms; Urethral; Urogenital; Youth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment

  Day 28-follow-up visit

Study Arms (1)

Azithromycin

EXPERIMENTAL

Azithromycin 1 gm PO single dose given as directly observed

Drug: Azithromycin

Interventions

Azithromycin DRUG

Azithromycin 1 gm PO single dose given as directly observed

Azithromycin

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Los Angeles County Department of Health Services - Juvenile Court Health Services

Los Angeles, California, 90031, United States

Location

MeSH Terms

Conditions

Chlamydia Infections

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Limitations and Caveats

In September 2018, the decision was made to stop enrollment early due to changes in the LA Public Health and YCF standard facility management systems; research staff were not able to overcome the resulting challenges making enrollment infeasible.

Results Point of Contact

• Title: Jeannette Lee
• Organization: University of Arkansas for Medical Sciences

jylee@uams.edu

501-526-6712

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 15, 2017
• Study Start: August 24, 2017
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-09

Locations

US (1)