Latent Tuberculosis Clinical Trial
Official title:
Six Weeks of Daily Rifapentine vs. a Comparator Arm of 12-16 Week Rifamycin-based Treatment of Latent M. Tuberculosis Infection: Assessment of Safety, Tolerability and Effectiveness
This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05073926 -
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
|
||
Not yet recruiting |
NCT04428294 -
Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
|
Phase 4 | |
Completed |
NCT02276755 -
Vitamin D Supplementation in TB Prevention
|
Phase 3 | |
Withdrawn |
NCT03498534 -
Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
|
Phase 4 | |
Active, not recruiting |
NCT03988933 -
2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB.
|
Phase 2 | |
Recruiting |
NCT06022146 -
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
|
Phase 3 | |
Active, not recruiting |
NCT04188041 -
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
|
N/A | |
Recruiting |
NCT03730181 -
Tuberculosis Clinical Trials Consortium Study 35
|
Phase 1/Phase 2 | |
Completed |
NCT01967134 -
Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
|
Phase 1 | |
Completed |
NCT00257907 -
Immune Response to Mycobacterium Tuberculosis Infection
|
||
Recruiting |
NCT05756582 -
Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
|
||
Active, not recruiting |
NCT04557176 -
TB Screening Improves Preventive Therapy Uptake
|
N/A | |
Completed |
NCT02119130 -
Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa
|
N/A | |
Not yet recruiting |
NCT06281834 -
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
|
Phase 1 | |
Not yet recruiting |
NCT02512484 -
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments
|
N/A | |
Completed |
NCT00763295 -
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
|
N/A | |
Completed |
NCT01850043 -
The Epidemiology of TST Change in Korea
|
N/A | |
Completed |
NCT02073669 -
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
|
N/A | |
Completed |
NCT02090374 -
Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen
|
N/A | |
Completed |
NCT02880982 -
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
|
Phase 3 |