Could a 3-Day antibiotic course beat the standard 7 days for chlamydia?
NCT ID NCT05840159
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed phase 4 trial tested whether taking doxycycline for 3 days works as well as the usual 7-day course for treating chlamydia. About 526 men and women with confirmed chlamydia took either a 3-day or 7-day regimen, with placebo pills used to keep the study blinded. Participants were tested again 28 days later to see if the infection was cleared.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxycycline
- What this could lead to
- If successful, this could show that a shorter 3-day course of doxycycline is just as effective as the standard 7-day course for treating chlamydia, potentially simplifying treatment.
- What could go wrong
- This is a completed phase 4 trial, so results are available. However, the shorter regimen may not be as effective in all patients, and the study only looked at specific groups (women with urogenital infection and men with rectal infection).
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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526 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Feb 2026
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 \*Point-of-care (POC) test may or may not be FDA-cleared for CLIA waiver for diagnosis depending upon anatomic site of infection. 2. Must be age \>/=16 years (where the 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 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. 2. 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. 3. 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. 4. 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). 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. 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 per clinic standard practice and in accordance with local guidelines without concomitant azithromycin or other treatment for Chlamydia trachomatis infection. * Clinical diagnosis of concomitant untreated primary or secondary syphilis or known exposure to syphilis * Urethritis among men * Contraception status * Diagnosis of HIV
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University Hospital Midtown - Emory Clinic Infectious Diseases
Atlanta, Georgia, 30308, United States
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Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
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KEMRI-CCR PHRD Project
Thika, Kenya
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Pwani Research Centre
Mombasa, Kenya
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University of Alabama at Birmingham School of Medicine - Infectious Disease
Birmingham, Alabama, 35222, United States
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University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, 14642-0001, United States
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University of Washington - Harborview Medical Center - Center for AIDS and STD
Seattle, Washington, 98104-2433, United States
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