Short Course Regimen of Doxycycline for the Treatment of Chlamydial Infection

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Participants will take a 3-day course of doxycycline or a 7-day course of doxycycline to treat urogenital chlamydia infections (women) and rectal infections (men).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Infectious Diseases Clinical Research Consortium
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

1. Has untreated urogenital CT (in persons AFAB) or rectal CT (in persons AMAB), diagnosed by a positive NAAT result or point-of care test result within 14 days

2. Must be age ≥16 years (where the Institutional Review Board (IRB) permits individuals aged 16-17 years old to consent to research); otherwise age > 18 years

3. Willing and able to understand and provide written informed consent before initiation of any study procedures

4. Willing to complete a 7-day study drug regimen

5. Willing to abstain from condomless anal or vaginal sex during the trial

6. Willing and able to adhere to planned study procedures for all study visits

7. Has valid contact information

Exclusion Criteria:

1. For persons AFAB: lower abdominal or pelvic pain or other signs or symptoms consistent with a clinical diagnosis of pelvic inflammatory disease (PID)

2. Signs and symptoms that, in the judgement of a qualified clinician, warrant a prolonged course of treatment with doxycycline

3. Received antimicrobial therapy active against C. trachomatis within 21 days prior to positive CT test result, or between the positive CT test result and study enrollment

4. Planning to take antimicrobial therapy active against CT during the study period (e.g. doxycycline post-exposure prophylaxis, treatment for Mycoplasma genitalium infection, acne, or any other non-STI medical condition)

5. Currently enrolled in or plan to enroll in another study using antimicrobial therapy active against C. trachomatis during the study period

6. Pregnant or lactating, or plan to become pregnant within the study period

7. Known moderate to severe allergy to tetracyclines, excluding tetracycline-induced photosensitivity

8. Plan to move or travel to another location that would preclude study follow-up appointments in clinic in the next 30 days

9. 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)

10. Previous enrollment in this trial

11. Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety or determination of study endpoints