Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities (NCT00980148) | Clinical Trial Compass
CompletedPhase 3
Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
United States567 participantsStarted 2009-12-02
Plain-language 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.
Who can participate
Age range
12 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.
Timeframe: Study visit # 2 (Day 28 after therapy started)
Trial details
NCT IDNCT00980148
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)