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Tetracycline Antibiotic
Doxycycline for Chlamydia
Phase 4
Recruiting
Led By Julia Dombrowski, MD, MPH
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day1 through day 29
Awards & highlights
Study Summary
This trial will test different courses of doxycycline to treat chlamydia infections in men and women.
Who is the study for?
This trial is for individuals aged 16 or older with untreated chlamydia, willing to take a week-long drug regimen and abstain from unprotected sex during the study. Pregnant or breastfeeding individuals, those on certain medications, planning pregnancy, moving away soon, or with severe allergies to tetracyclines are excluded.Check my eligibility
What is being tested?
The study compares two doxycycline treatment regimens for chlamydia: one group takes it for 3 days followed by a placebo for 4 days; the other takes it for a full week. Participants are randomly assigned to these groups and re-tested after four weeks using NAAT.See study design
What are the potential side effects?
Doxycycline may cause side effects like stomach upset, diarrhea, sun sensitivity (increased risk of sunburn), allergic reactions in some people, and rarely changes in blood pressure or kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day1 through day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1 through day 29
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of assigned female at birth (AFAB) participants with microbiologic cure as detected via vaginal swab
Proportion of assigned male at birth (AMAB) participants with microbiologic cure as detected via rectal swab
Secondary outcome measures
Proportion of assigned female at birth (AFAB) participants with microbiologic cure as detected via rectal swab
Proportion of assigned female at birth (AFAB) participants with microbiologic cure at all anatomic sites that were positive at baseline
Proportion of assigned male at birth (AMAB) participants with microbiologic cure as detected via urine
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3Experimental Treatment2 Interventions
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.
Group II: Arm 1Experimental Treatment2 Interventions
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.
Group III: Arm 2Active Control1 Intervention
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.
Group IV: Arm 4Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
2008
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,484,573 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,559,993 Total Patients Enrolled
Infectious Diseases Clinical Research ConsortiumUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to take antibiotics that work against chlamydia during the study.I experience lower abdominal or pelvic pain and may have pelvic inflammatory disease.My doctor thinks I need a long-term treatment with doxycycline.I have untreated chlamydia, confirmed by a test within the last 14 days.I haven't taken medications like retinoids or warfarin in the last 7 days.I am at least 16 years old, or 18 where required.I am willing to avoid unprotected sex during the trial.I haven't taken specific antibiotics for chlamydia in the last 21 days.I am participating in another study using treatments for C. trachomatis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 3
- Group 3: Arm 2
- Group 4: Arm 4
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the study currently recruiting participants?
"Per the clinicaltrials.gov website, this trial has closed its recruitment period and is no longer searching for potential candidates. Initially posted on June 1st 2023 and updated as recently as April 21st 2023, there are 761 other studies actively recruiting patients at present."
Answered by AI
Has the three-day regimen of doxycycline been sanctioned by the FDA?
"Leveraging the Phase 4 trial data, our team at Power determined that 3-Day Regimen of Doxycycline had an overall safety rating of 3."
Answered by AI
Are there myriad locations in Canada undertaking this trial?
"According to the protocol, Grady Infectious Diseases Clinic (Ponce Clinic) in Rochester, University of Rochester in Seattle, and University of Washington Harborview Medical Center in Mombasa are 3 sites participating. Additionally, there exist 6 additional clinical trial locations."
Answered by AI
What are the goals of this experimental endeavor?
"The primary outcome that will be assessed after 29 days is the Number of Participants with Microbiological Cure of Urogenital Infection in Persons Assigned Female at Birth (AFAB). Subsequent measures include: Quantity of Patients with a Negative NAAT Result for Urethral Infection in Males, Amount of Subjects Achieving Total CT Eradication from AFAB Anatomic Sites, and Sum of People Reaching Total CT Removal from AMAB Locations."
Answered by AI
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