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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
Pivotal Trial
Drug Has Already Been Approved
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
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.
Trial 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
~2650
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,319 Previous Clinical Trials
5,547,496 Total Patients Enrolled
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,254 Total Patients Enrolled
Infectious Diseases Clinical Research ConsortiumUNKNOWN
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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.
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