Chlamydial Infection Clinical Trial
Official title:
Randomized Clinical Trial Evaluating Treatment Failure Following Recommended Therapy (Azithromycin Versus Doxycycline) for Genital Chlamydial Infection in Males and Females in Youth Correctional Facilities
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.
Status | Completed |
Enrollment | 567 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 21 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama Hospital - Infectious Diseases | Birmingham | Alabama |
United States | Los Angeles County Department of Public Health - Sexually Transmitted Disease Program | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant). | Study visit # 2 (Day 28 after therapy started) | No |
Secondary | Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome. | Baseline and study visit #2 (Day 28 after therapy is started) | No |
Status | Clinical Trial | Phase | |
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