Tuberculosis, Pulmonary Clinical Trial
Official title:
Efficacy and Safety of Short-course Treatment for Drug-sensitive Tuberculosis in China
Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens. This is a multicenter prospective, non-inferiority randomized controlled study. The purpose of our study is a) to evaluate the tolerability, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of the high-dose rifapentine, b) to evaluate whether the high-dose rifapentine-containing regimen has the potential to treat the rifampicin-sensitive pulmonary tuberculosis and shorten the course of treatment to 17 weeks. This study is of great significance for shortening the course of treatment, reducing the adverse reactions and economic burden of patients' treatment in rifampicin-sensitive tuberculosis patient.
Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens. Incomplete TB treatment can lead to increased morbidity and mortality, prolonged infectivity and transmission, and the development of drug resistance. The development of new therapeutic strategies with stronger bactericidal activity could lead to shorter and better-tolerated regimens, thereby increasing cure rates, lowering costs, potentially reducing transmission and preventing the emergence of multidrug-resistant tuberculosis (MDR-TB). This trial is a multicenter prospective, non-inferiority randomized controlled study. Rifampicin-sensitive pulmonary tuberculosis patients will be included in our study. Stage 1 of the study is designed to evaluate the tolerability, efficacy and PK/PD of the high-dose rifapentine in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected rifapentine doses in patients with rifampicin-sensitive pulmonary tuberculosis. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06084715 -
The INSTITUT Study
|
||
Terminated |
NCT03028129 -
Prevention of Tuberculosis in Prisons
|
Phase 4 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Withdrawn |
NCT03862248 -
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
|
Phase 3 | |
Completed |
NCT03271567 -
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Active, not recruiting |
NCT04919239 -
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
|
Phase 2 | |
Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
Recruiting |
NCT05926466 -
BTZ-043 Dose Evaluation in Combination and Selection
|
Phase 2 | |
Recruiting |
NCT04752592 -
Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Not yet recruiting |
NCT04968886 -
TuBerculosis Viability Interregional Study and Agreement on Biological Tests
|
||
Not yet recruiting |
NCT04485156 -
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
|
Phase 3 | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT01364324 -
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
|
||
Active, not recruiting |
NCT04179500 -
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers
|
Phase 2 | |
Completed |
NCT05899400 -
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
|
||
Completed |
NCT04938596 -
Airborne Preventive Measures to Reduce New TB Infections in Household Contacts
|
N/A | |
Recruiting |
NCT05455112 -
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
|
Phase 2 | |
Completed |
NCT03044158 -
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
|
N/A |