A Study of Doxycycline to Treat Chlamydial Infection (NCT05840159) | Clinical Trial Compass
CompletedPhase 4
A Study of Doxycycline to Treat Chlamydial Infection
United States526 participantsStarted 2024-01-19
Plain-language summary
This is a Phase 4 blinded, randomized, active-controlled, non-inferiority trial. Final evaluable population will include a minimum 596 individuals: 298 women with confirmed urogenital chlamydia (CT) and 298 men with confirmed rectal chlamydia (CT). Approximately 664 participants will be enrolled to achieve a minimum 596 participants who contribute primary outcome data. Randomization will be stratified by study site and sex: 332 women and 332 men. Participants will be randomized 1:1 to a 3-day regimen of doxycycline or a 7-day regimen of doxycycline. The study blind will be maintained by providing 7 days of identical pre-filled blister packs, one with 3 days of active treatment and 4 days of placebo, and the other with 7 days of active treatment. Participants will be asked to return 28 days after randomization (at day 29), at which time they will be re-tested for chlamydia (CT) using a laboratory-based chlamydia (CT) nucleic acid amplification test (NAAT).
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Has untreated urogenital chlamydia (CT) (in women) or rectal CT (in men), diagnosed with a positive nucleic acid amplification test (NAAT) (point-of care or laboratory-based)\* result within 14 days
✓. Must be age \>/=16 years (where the IRB permits individuals aged 16-17 years old to consent to research); otherwise age \>/= 18 years
✓. Willing and able to understand and provide written informed consent before initiation of any study procedures
✓. Willing to complete a 7-day study drug regimen
✓. Willing to abstain from condomless anal or vaginal sex during the trial
✓. Willing and able to adhere to planned study procedures for all study visits
✓. Has valid contact information
Exclusion criteria
✕. For women: lower abdominal or pelvic pain or other signs or symptoms consistent with a clinical diagnosis of pelvic inflammatory disease (PID) Per the CDC's 2021 STD Treatment Guidelines or refer to local guidelines.
What they're measuring
1
Proportion of assigned men participants with microbiologic cure as detected via rectal swab
Timeframe: Day 1 through Day 29
2
Proportion of assigned women participants with microbiologic cure as detected via vaginal swab
Timeframe: Day1 through Day 29
Trial details
NCT IDNCT05840159
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Signs and symptoms that, in the judgement of a qualified clinician, warrant a prolonged course of treatment with doxycycline For example, 21 days of doxycycline for presumed lymphogranuloma venereum infection.
✕. Received antimicrobial therapy active against C. trachomatis within 21 days prior to positive chlamydia (CT) test result, or between the positive chlamydia (CT) test result and study enrollment Use of the following antibiotics is exclusionary: doxycycline and related tetra- or glycylcyclines, macrolides (including azithromycin), fluoroquinolones, rifampin, quinupristin-dalfopristin, and linezolid. Note: Amoxicillin, penicillin, ceftriaxone, and other beta-lactam antibiotics are not considered exclusionary for this study.
✕. Planning to take antimicrobial therapy active against chlamydia (CT) during the study period (e.g. doxycycline post-exposure prophylaxis, treatment for Mycoplasma genitalium infection, acne, or any other non-STI medical condition).
✕. Currently enrolled in or plan to enroll in another study using antimicrobial therapy active against C. trachomatis during the study period
✕. Pregnant or lactating, or plan to become pregnant within the study period
✕. Known moderate to severe allergy to tetracyclines, excluding tetracycline-induced photosensitivity.
✕. Plan to move or travel to another location that would preclude study follow-up appointments in clinic in the next 30 days