Clinical trials: Rifampicin Resistant Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis Patients
Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults
The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults.
- Trial name
- WX081-DDI (NCT06701136)
- Testing
- Sudapyridine, Itraconazole, Rifampin
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Tuberculosis, Multidrug-Resistant
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis
Acquired drug-resistance is a major challenge for tuberculosis (TB) care programs. The 2020 WHO guidelines recommends replacing second-line injectables by bedaquiline in rifampicin-resistant TB (RR-TB) treatment regimens.
- Trial name
- Stake (NCT05555303)
- Testing
- Amikacin
- Where
- Rwanda
- Volunteers
- 20 people
- Sponsor
- Rwanda Biomedical Centre
Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis, Type 2 Diabetes Mellitus (T2DM)
A Study on the Short - Course Treatment Regimen Containing Pretomanid for Diabetes Mellitus Complicated With Rifampicin - Resistant/Multidrug - Resistant Pulmonary Tuberculosis
The treatment of rifampicin-resistant/multidrug-resistant pulmonary tuberculosis (RR-TB) is characterized by a long treatment course, a high incidence of adverse reactions, a low cure rate, and a high recurrence rate.
- Conditions
- Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis, Type 2 Diabetes Mellitus (T2DM), Pretomanid
- Trial name
- NCT07191834
- Volunteers
- 60 people
- Sponsor
- Wuhan Pulmonary Hospital
Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant…
- Trial name
- WISH (NCT05824871)
- Testing
- Sudapyridine, Bedaquiline
- Where
- 2 sites in China
- Volunteers
- 450 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Rifampicin Resistant Tuberculosis, Drug-resistant Tuberculosis
Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial
The primary aim of this pragmatic trial is to determine the effectiveness of a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB)…
- Conditions
- Rifampicin Resistant Tuberculosis, Drug-resistant Tuberculosis, Multidrug Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- SMARTT (NCT05017324)
- Testing
- WGS DST strategy
- Where
- South Africa
- Volunteers
- 248 people
- Sponsor
- Universiteit Antwerpen
Tuberculosis, Pre-XDR-TB
Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care
BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid…
- Conditions
- Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04062201
- Testing
- Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form
- Where
- 2 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Wits Health Consortium (Pty) Ltd
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR
- Trial name
- PRISM-TB (NCT06441006)
- Testing
- Bedaquiline, Linezolid, Pretomanid
- Where
- 6 sites in Mongolia, Pakistan and 3 more
- Volunteers
- 400 people
- Sponsor
- University of California, San Francisco
Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
Shortening Treatment by Advancing Novel Drugs
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with…
- Trial name
- STAND (NCT02342886)
- Testing
- Moxifloxacin, PA-824, Pyrazinamide
- Where
- 26 sites in Georgia, Kenya and 6 more
- Volunteers
- 284 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Pulmonary
Accuracy and Feasibility of Xpert Ultra
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens.
- Trial name
- NCT03072576
- Testing
- Xpert MTB/RIF Ultra
- Where
- 6 sites in Belarus, Georgia and 2 more
- Volunteers
- 1,400 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
MDR Tuberculosis, Resistance to Tuberculostatic Drugs
Artificial Inteligent for Diagnosing Drug-Resistant Tuberculosis
Title: Artificial Neural Network as Diagnostic Tools For Rifampicin-Resistant Tuberculosis In Indonesia. A Predictive Model Study and Economic Evaluation.
- Trial name
- NCT04208789
- Testing
- Rapid Molecular Drug-Resistant Tuberculosis Test, Artificial Intelligent Model, Drug Susceptibility Test
- Where
- 5 sites in Indonesia
- Volunteers
- 524 people
- Sponsor
- Hasanuddin University
Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis
Line Probe Assay Evaluation Study
This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from…
- Conditions
- Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis, Rifampicin Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- YD (NCT02984579)
- Testing
- YD REBA MTB-MDR, Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2
- Volunteers
- 888 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis
Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course…
- Conditions
- Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis, MDR-TB, RR-TB
- Trial name
- AHA-PLUS (NCT07393438)
- Testing
- Acetohydroxamic Acid
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Tuberculosis, Rifampicin Resistant Tuberculosis
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with…
- Trial name
- NCT05586230
- Testing
- Pretomanid, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
- Where
- 5 sites in Brazil, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Latent Tuberculosis, Staphylococcus Aureus
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Two commonly used treatments for latent tuberculosis infection are either 4 months rifampicin or 6-9 months isoniazid. The invistigators will study the risk of acquisition of rifampicin resistance in commensal Staphylococcus…
- Trial name
- NCT05073926
- Testing
- No intervention is part of the study protocol
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Region Skane
Drug-resistant Tuberculosis, Pulmonary Tuberculosis
Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort
This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B)…
- Conditions
- Drug-resistant Tuberculosis, Pulmonary Tuberculosis, Rifampin-resistant Tuberculosis
- Trial name
- INSPIRE-BDLL (NCT06649721)
- Testing
- bedaquiline, delamanid, linezolid
- Where
- 34 sites in China
- Volunteers
- 120 people
- Sponsor
- Huashan Hospital
Rifampicin-Resistant Tuberculosis
A 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis
This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa.
- Trial name
- MDR-ENDPlus (NCT07675954)
- Testing
- MDR-END Plus regimen, Standard-of-care (SoC) treatment
- Where
- 2 sites in South Africa
- Volunteers
- 294 people
- Sponsor
- Seoul National University Hospital
Tuberculosis, Pulmonary
Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB
The overall goal of this exploratory proof-of-concept study is to determine whether, in participants with pulmonary tuberculosis caused by M.
- Trial name
- NCT03174184
- Testing
- Rifampin, MEROPENEM 2 grams TID, MEROPENEM 1 gram TID
- Where
- South Africa
- Volunteers
- 112 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Pulmonary
A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB
To assess outcome of treatment and safety among patients with rifampicin-resistant isoniazid-susceptible pulmonary tuberculosis treated with a novel regimen consisting of isoniazid, bedaquiline, and moxifloxacin throughout for 6…
- Trial name
- NCT06526039
- Testing
- a novel short regimen
- Volunteers
- 100 people
- Sponsor
- Taipei Medical University WanFang Hospital
Tuberculosis
Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects
This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for pulmonary TB.
- Trial name
- NCT01587469
- Where
- United States
- Volunteers
- 992 people
- Sponsor
- Cepheid
Pulmonary Tuberculosis
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid…
- Trial name
- NCT05971602
- Testing
- Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)
- Where
- 13 sites in Philippines, South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute