Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
Condition: Chlamydial Infection
MeSH terms: Infections; Communicable Diseases; Chlamydia Infections
Intervention: Azithromycin; Doxycycline
Intervention description: FDA approved, a 1 gm single dose, two 500 mg tablets.; FDA approved, a 100 mg capsule twice a day for 7 days.
Intervention MeSH terms: Azithromycin; Doxycycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 567.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Chlamydia trachomatis, Chlamydia, Doxycycline, Azithromycin

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