Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Chlamydia is a common infection among youth and can be given from one person to another during sex. Many people who have chlamydia have no signs of infection at all, but can pass the infection to anyone they have sex with. If not treated, chlamydia can lead to serious health problems. This study will look at how well medicines given for chlamydia infection work. The study requires 306 evaluable subjects, chlamydia-positive, males and non-pregnant females, ages 12-21, living in long-term, gender-segregated youth correctional facilities. Participants will be assigned to receive either doxycycline (2 times per day, by mouth, for 7 days) or azithromycin (1 single dose by mouth). Study procedures will include collection of at least 3 urine samples to test for chlamydia. Study visits will occur during initial enrollment in the study, day 28 after starting treatment, and day 67. Participants will be involved in study related procedures for up to 67 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Azithromycin; Doxycycline

Criteria

Inclusion Criteria:

• Males and females between the ages of 12 and 21 years

• Residing in a long-term gender-segregated (no co-ed) youth correctional facility (YCF)

• Diagnosed with genital chlamydia as determined by a screening C. trachomatis nucleic acid amplification test (NAAT)

• Anticipated length of stay at the YCF at the time of enrollment is > 3 weeks

• Willingness to provide written consent

• Willingness to comply with study procedures

Exclusion Criteria:

• Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae nucleic acid amplification test (NAAT)

• Clinical diagnosis of pelvic inflammatory disease (PID) or epididymitis based on review of medical records

• Known allergy to tetracyclines or macrolides

• Currently pregnant or breastfeeding

• History of photosensitivity related to doxycycline use

• 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

• Any concomitant infection, which requires antimicrobial therapy with activity against C. trachomatis

• Previously enrolled in this study

• Unable to swallow pills

• Other exclusion criteria, per clinician judgment, that prohibits subject from enrolling in study

• Of note, current use of oral contraceptive agents (OCPs) is not an exclusion criterion