Clinical trials: Tuberculosis, Multidrug-Resistant
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, 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.
Drug-resistant Tuberculosis, HIV Coinfection
Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.
- Conditions
- Drug-resistant Tuberculosis, HIV Coinfection, Cost-Benefit Analysis
- Trial name
- TSELiOT (NCT05553236)
- Testing
- Targeted next-generation sequencing
- Where
- South Africa
- Volunteers
- 2,500 people
- Sponsor
- University of California, San Francisco
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
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
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
Pulmonary Tuberculosis
A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture…
- Trial name
- NCT02333799
- Testing
- Bedaquiline, PA-824, Linezolid
- Where
- 3 sites in South Africa
- Volunteers
- 109 people
- Sponsor
- Global Alliance for TB Drug Development
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
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
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
Drug Resistant Tuberculosis, MDR-TB
Triage Test for All Oral DR-TB Regimen (TRiAD Study)
A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB-A multi-centre, multi-country…
- Conditions
- Drug Resistant Tuberculosis, MDR-TB, XDR-TB, Tuberculosis
- Trial name
- NCT05175794
- Testing
- Xpert® MTB/XDR
- Where
- 4 sites in Ethiopia, Nigeria and 1 more
- Volunteers
- 786 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Tuberculosis, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multi Drug Resistant, Strains
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge in Central Africa. Understanding the molecular epidemiology and genotypic characteristics of MDR-TB strains is crucial for effective control measures.
- Conditions
- Tuberculosis, Multi Drug Resistant, Strains, Molecular Epidemiology, Multi Drug Resistant Tuberculosis
- Trial name
- MESTCAR (NCT07017803)
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Pulmonary Disease, Tuberculosis, Pulmonary
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to…
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04493671
- Testing
- TBAJ-876 suspension, TBAJ-876 100 mg tablet, TBAJ-876 25 mg tablet
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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
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
Tuberculosis, Thoracic Surgery
Study of TB Lesions Obtained in Therapeutical Surgery
The correlation of the morphologic, microbiological, genetic and histopathological characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential…
- Conditions
- Tuberculosis, Thoracic Surgery, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
- Trial name
- SH-TBL (NCT02715271)
- Testing
- therapeutical surgery for TB
- Where
- Georgia
- Volunteers
- 192 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
Tuberculosis, Multidrug-Resistant, Infection, Bacterial
Evaluating Newly Approved Drugs for Multidrug-resistant TB
endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).
- Conditions
- Tuberculosis, Multidrug-Resistant, Infection, Bacterial, Pulmonary Tuberculoses
- Trial name
- endTB (NCT02754765)
- Testing
- Bedaquiline, Delamanid, Clofazimine
- Where
- 12 sites in Georgia, India and 5 more
- Volunteers
- 754 people
- Sponsor
- Médecins Sans Frontières, France
Tuberculosis, Multidrug-Resistant, Tuberculosis
Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)
endTB-Q Clinical Trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of two new, all-oral, shortened regimens for multidrug-resistant tuberculosis…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary Tuberculoses, Mycobacterial Infections
- Trial name
- endTB-Q (NCT03896685)
- Testing
- Bedaquiline 100 MG, Delamanid 50 MG Oral Tablet, Clofazimine 100 MG Oral Capsule
- Where
- 10 sites in India, Kazakhstan and 4 more
- Volunteers
- 323 people
- Sponsor
- Médecins Sans Frontières, France
Tuberculosis, Multidrug-Resistant
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB)…
- Trial name
- NCT02365623
- Testing
- TMC207 (bedaquiline), Background Regimen (BR)
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Janssen Pharmaceutical K.K.