Status:
COMPLETED
Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chlamydial Infection
Eligibility:
All Genders
12-21 years
Phase:
PHASE3
Brief 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 anyo...
Detailed Description
Genital chlamydia is a public health concern. The World Health Organization (WHO) estimates that 90 million of all new cases of sexually transmitted diseases (STDs) per year are caused by Chlamydia (C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
567 Patients enrolled
Trial Details
Trial ID
NCT00980148
Start Date
December 1 2009
End Date
May 1 2014
Last Update
March 18 2015
Active Locations (2)
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1
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, United States, 35249-0001
2
Los Angeles County Department of Public Health - Sexually Transmitted Disease Program
Los Angeles, California, United States, 90007-2608