Clinical trials: Rifampin-resistant Tuberculosis
Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB).
- Trial name
- INSPIRE-CODA (NCT06081361)
- Testing
- Bedaquiline, Delamanid, Contezolid
- Where
- 39 sites in China
- Volunteers
- 186 people
- Sponsor
- Beijing Chest Hospital
Drug Resistant Tuberculosis
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
The goal of the BringBPaL2Me Trial, a multi-principal investigator, multi-site, cluster randomized, non-inferiority trial is to compare nurse-led RR-TB treatment in primary care clinics to standard of care physician-led RR-TB…
- Trial name
- NCT05671718
- Testing
- Nurse-Led Treatment in Primary Care
- Where
- 5 sites in South Africa
- Volunteers
- 2,944 people
- Sponsor
- Johns Hopkins University
Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis
Novel Triple-dose Tuberculosis Retreatment Regimen
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent…
- Conditions
- Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs
- Trial name
- Tri-Do-Re (NCT04260477)
- Testing
- 6EH³R³Z, 6EHRZ
- Where
- Niger
- Volunteers
- 370 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Tuberculosis, Multidrug-Resistant
Bioneer Q-RFIA Clinical Evaluation
Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both…
- Trial name
- NCT05117788
- Testing
- Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac
- Where
- 5 sites in Kenya, Moldova and 3 more
- Volunteers
- 2,350 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Pulmonary Tuberculosis Without Resistance to Rifampicin
Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
The current standard short-course treatment for pulmonary TB requires 6 months to complete. This long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-TB drugs.
- Trial name
- NCT01994460
- Testing
- Linezolid, Ethambutol
- Where
- 3 sites in South Korea
- Volunteers
- 429 people
- Sponsor
- Seoul National University Hospital
Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in…
- Conditions
- Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis, Pre-XDR-TB
- Trial name
- INSPIRE-TB (NCT05081401)
- Testing
- Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z, A1, A2a
- Where
- 5 sites in China
- Volunteers
- 1,050 people
- Sponsor
- Huashan Hospital
Pulmonary Tuberculosis
The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)
The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary…
- Trial name
- NCT06476210
- Testing
- BDL regimen
- Where
- 7 sites in China
- Volunteers
- 45 people
- Sponsor
- Beijing Chest Hospital
Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis
Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With Resistant Tuberculosis: A Clinical Trial
Tuberculosis increases energy demands and protein breakdown, leading to muscle wasting. Malnutrition and minimal weight gain less than 5% in first two months predict treatment failure.
- Conditions
- Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis, Pre-xdr tb
- Trial name
- NCT07058233
- Testing
- Oral nutritional supplementation
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- RSUP Persahabatan
Multidrug- and Rifampicin-resistant Tuberculosis
BPaL(M) Regimen for the Treatment of MDR/RR-TB
The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid, Linezolid for 26 weeks for the treatment of MDR/RR-TB…
- Trial name
- NCT05381194
- Testing
- BPaL(M) regimen
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Asan Medical Center
Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with…
- Conditions
- Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
- Trial name
- NCT07170800
- Testing
- JDB0131 100mg, JDB0131 200mg, Delamanid (D)
- Where
- 7 sites in China
- Volunteers
- 60 people
- Sponsor
- WestVac Biopharma Co., Ltd.
HIV Infection, Pulmonary TB
Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis
Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB patients. It has not been a major problem in HIV-negative individuals treated for TB treated with standard intermittent regimens.
- Trial name
- NCT00933790
- Testing
- ATT (Ethambutol, Pyrazinamide, INH, Rifampicin)
- Where
- 3 sites in India
- Volunteers
- 331 people
- Sponsor
- Tuberculosis Research Centre, India
Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis
Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort
The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older.
- Conditions
- Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Drug-resistant Tuberculosis
- Trial name
- INSPIRE-BLMZ (NCT07268664)
- Testing
- BLMZ
- Where
- 3 sites in China
- Volunteers
- 120 people
- Sponsor
- Beijing Chest Hospital
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or…
- Trial name
- QUANTUM-TB (NCT07209761)
- Testing
- Bedaquiline, Quabodepistat, Pretomanid
- Where
- 42 sites in China, Georgia and 8 more
- Volunteers
- 532 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
HIV Infections, Tuberculosis
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.
To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB).
- Trial name
- NCT00000796
- Testing
- Cycloserine, Ethionamide, Capreomycin sulfate
- Where
- 21 sites in United States
- Volunteers
- 525 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, HIV
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed…
- Trial name
- NCT02906007
- Testing
- Bedaquiline
- Where
- 4 sites in Haiti, South Africa
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation
French guidelines currently recommend to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending the results of drug…
- Trial name
- FAST-TB (NCT02231229)
- Testing
- PCR-based strategy, conventional therapy
- Where
- 2 sites in France
- Volunteers
- 204 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Tuberculosis, Multidrug Resistant Tuberculosis
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with…
- Trial name
- TEDITUB (NCT05534750)
- Testing
- Tedizolid arm (SIVEXTRO®), Linezolid arm (ZYVOXID®), Standard quadruple therapy arm
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Tuberculosis, Drug-resistant Tuberculosis
Evaluation of Centralised TB Assay Solutions
Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB.
- Trial name
- NCT04147676
- Where
- 6 sites in Georgia, Germany and 3 more
- Volunteers
- 1,050 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Rifampicin-resistant Tuberculosis
French National Cohort of Patients With Rifampicin-Resistant Tuberculosis
A major obstacle in the fight against multidrug-resistant tuberculosis is its treatment. In 2021, only 60% of patients with MDR/RR tuberculosis who received treatment globally were successfully cured, while 12% succumbed to the…
- Trial name
- CONTRol-TB (NCT06565806)
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Rifampin-resistant Tuberculosis, Drug-resistant Tuberculosis
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with…
- Trial name
- THERMOL (NCT06590428)
- Testing
- Therapeutic Drug Monitoring for Linezolid
- Where
- South Africa
- Volunteers
- 280 people
- Sponsor
- Albert Einstein College of Medicine