Actively Recruiting
Six Weeks of Daily Rifapentine Compared to 12-16 Week Rifamycin-Based Treatment for Latent Mycobacterium Tuberculosis Infection: Safety, Tolerability, and Effectiveness Assessment
Led by Centers for Disease Control and Prevention · Updated on 2026-05-06
3400
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new short 6-week daily rifapentine treatment compared to the standard 12-16 week rifamycin-based treatments for latent Mycobacterium tuberculosis infection (LTBI). This trial focuses on people at higher risk of developing active tuberculosis (TB) and is conducted in locations with varying TB rates where LTBI treatment is routinely provided. The study aims to determine if the shorter treatment is not less safe or effective than the longer standard treatments. Participants are randomly assigned to one of two treatment groups: the experimental group receives 600 mg of rifapentine daily for 6 weeks, while the control group receives one of three standard regimens lasting 12 to 16 weeks, including combinations of rifapentine, isoniazid, and rifampin. Dose adjustments are made based on patient weight following established guidelines. Treatments are given according to random assignment and participants are followed for 24 months to assess outcomes. During the study, researchers monitor treatment completion rates, adverse drug reactions, and new cases of active tuberculosis. Safety assessments include tracking serious side effects and drug discontinuation rates. Effectiveness is measured by the occurrence of culture-confirmed or clinical TB within 24 months of enrollment. The study involves regular evaluations and follow-up visits over two years to collect data on treatment tolerability, safety, and TB prevention outcomes.
CONDITIONS
Brief Title
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have latent tuberculosis infection confirmed by a positive tuberculin skin test or interferon gamma release assay
- Are at increased risk of active tuberculosis due to recent exposure, recent infection, HIV co-infection, certain medical conditions, or recent immigration
- Willing to provide informed consent or parental permission and assent for children
- Pregnant women in second or third trimester meeting specific study stage requirements
- Children under 12 years meeting specific study stage requirements
You will not qualify if you...
- No documented positive test for latent tuberculosis infection
- Currently breastfeeding
- Pregnant women in first trimester or intending pregnancy within 120 days
- Women of childbearing potential refusing contraception or abstaining from pregnancy risk
- Current or suspected active tuberculosis
- Tuberculosis resistant to rifamycin
- Prior recent treatment with rifamycin or isoniazid beyond specified limits
- History of completed adequate treatment for tuberculosis or latent infection if HIV-negative
- Allergy or intolerance to rifamycins
- Elevated liver enzymes beyond 5 times normal
- Taking medications that conflict with study drugs
- Weight under 25 kg if 12 years or older, or under 3 kg if younger than 12 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 16 weeks depending on assigned treatment
Participants receive assigned rifamycin-based drug treatment for latent tuberculosis infection according to their group allocation.
Weekly visits for up to 16 weeks
Duration - Up to 24 months
Participants are monitored for safety, tolerability, and effectiveness outcomes after completing treatment.
Periodic visits over 24 months
Trial Site Locations
Total: 21 locations
1
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Actively Recruiting
2
George Washington University
Washington D.C., District of Columbia, United States, 20001
Actively Recruiting
3
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States, 20001
Actively Recruiting
4
New York Harbor Healthcare System
Manhattan, New York, United States, 10001
Actively Recruiting
5
New York City Bureau of TB Control
New York, New York, United States, 11201
Actively Recruiting
6
San Antonio VA
San Antonio, Texas, United States, 78201
Active, Not Recruiting
7
Seattle King County Health Department
Seattle, Washington, United States, 98101
Actively Recruiting
8
Liverpool Hospital
Sydney, Australia
Actively Recruiting
9
Paramatta Chest
Sydney, Australia
Actively Recruiting
10
Royal Prince Alfred Hospital
Sydney, Australia
Actively Recruiting
11
National Referral University Hospital for Pneumo-physiology
Cotonou, Benin
Active, Not Recruiting
12
Calgary TB Clinic
Calgary, Alberta, Canada, T1Y 6H6
Actively Recruiting
13
Edmonton TB Clinic
Edmonton, Alberta, Canada
Actively Recruiting
14
British Columbia Centre for Disease Control
Vancouver, British Columbia, Canada
Actively Recruiting
15
Toronto Western Hospital
Toronto, Ontario, Canada, M5P 1N5
Actively Recruiting
16
McGill University Health Centre
Montreal, Quebec, Canada, H3A 0G4
Actively Recruiting
17
Les Centres Gheskio (INLR) CRS
Port-au-Prince, Haiti
Actively Recruiting
18
Desmond Tutu TB Center
Stellenbosch, South Africa
Not Yet Recruiting
19
Joint Clinical Research Centre/ Makerere Univ Med Sch
Kampala, Uganda
Actively Recruiting
20
Ho Chin Minh City-District 6 TB Unit
Ho Chi Minh City, Vietnam
Actively Recruiting
21
Ho Chin Minh City-Phoi Viet Resportory Centre
Ho Chi Minh City, Vietnam
Actively Recruiting
Research Team
A
Amber B Robinson, PhD
T
TBTC Research Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here