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YCFM (Youth Correctional Facilities Males)

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ClinicalTrials.gov Identifier: NCT03249935
Recruitment Status : Completed
First Posted : August 15, 2017
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
Chlamydial Infection Drug: Azithromycin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Failure and Associated Predictors Following Azithromycin Treatment for Urogenital Chlamydial Infection in Males in Youth Correctional Facilities
Actual Study Start Date : August 24, 2017
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms [ Time Frame: Day 28-follow-up visit ]
    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.


Secondary Outcome Measures :
  1. Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment [ Time Frame: Day 28-follow-up visit ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249935


Locations
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United States, California
Los Angeles County Department of Health Services - Juvenile Court Health Services
Los Angeles, California, United States, 90031
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  Study Documents (Full-Text)

Documents provided by National Institute of Allergy and Infectious Diseases (NIAID):

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03249935     History of Changes
Other Study ID Numbers: 16-0002
HHSN272201300012I
First Posted: August 15, 2017    Key Record Dates
Results First Posted: October 28, 2019
Last Update Posted: October 28, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Azithromycin
Chlamydia
Correctional
Facilities
Symptoms
Urethral
Urogenital
Youth
Additional relevant MeSH terms:
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Infection
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female