Phase 3 N=567 Randomized Treatment

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

Chlamydial Infection

Bottom Line

View on ClinicalTrials.gov: NCT00980148 ↗

Enrolled (actual)

567

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: 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. — 3.2; 0.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Azithromycin (Drug); Doxycycline (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
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.	3.2; 0.0	—
SECONDARY Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00980148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.