A Study of Doxycycline to Treat Chlamydial Infection
Chlamydial Infection
About this trial
This is an interventional treatment trial for Chlamydial Infection focused on measuring Chlamydia, Doxycycline, Infection, intervention, Phase 4
Eligibility Criteria
Inclusion Criteria: Has untreated urogenital chlamydia (CT) (in persons assigned female sex at birth (AFAB)) or rectal CT (in persons assigned male sex at birth (AMAB)), diagnosed with a positive nucleic acid amplification test (NAAT) result or point-of care test * result within 14 days *Point-of-care test may or may not be FDA-cleared for CLIA waiver for diagnosis depending upon anatomic site of infection. 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 persons assigned female sex at birth (AFAB): 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 WHO Guidelines for the management of symptomatic STIs 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 Use of a medication contraindicated to treatment with doxycycline within 7 days prior to enrollment or during the study period (systemic retinoids, barbiturates, carbamazepine, phenytoin, warfarin) Previous enrollment in this trial Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety or determination of study endpoints. Of note, the following factors will NOT exclude participants from the study: Concomitant untreated gonorrhea (rectal, pharyngeal, or urethral) or known exposure to gonorrhea in the time between CT testing and study enrollment. Gonococcus (GC) infection identified during the course of pre-screening or screening will be treated with a single dose of ceftriaxone 500mg IM without concomitant azithromycin treatment. Clinical diagnosis of concomitant untreated primary or secondary syphilis or known exposure to syphilis Urethritis among persons AMAB Contraception status Diagnosis of HIV
Sites / Locations
- Grady Memorial Hospital
- Emory University Hospital Midtown - Emory Clinic Infectious Diseases
- University of Rochester Medical Center - Vaccine Research Unit
- University of Washington - Harborview Medical Center - Center for AIDS and STD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Arm 1
Arm 2
Arm 3
Arm 4
100 mg of doxycycline orally administered twice daily for 3 days and 4 days of placebo to assigned female at birth (AFAB) participants >/= 16 years old with confirmed urogenital Chlamydia trachomatis (CT). N=166.
100 mg of doxycycline orally administered twice daily for 7 days to assigned female at birth (AFAB) participants >/= 16 years old with confirmed urogenital Chlamydia trachomatis (CT). N=166.
100 mg of doxycycline orally administered twice daily for 3 and 4 days of placebo days to assigned male at birth (AMAB) participants >/= 16 years old with confirmed rectal Chlamydia trachomatis (CT). N=166.
100 mg of doxycycline orally administered twice daily for 7 days to assigned male at birth (AMAB) participants >/= 16 years old with confirmed rectal Chlamydia trachomatis (CT). N=166.