Clinical trials: Extensively Drug-Resistant Tuberculosis
Tuberculosis, Multidrug Resistant Tuberculosis
An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional…
- Conditions
- Tuberculosis, Multidrug Resistant Tuberculosis, Extensively-drug Resistant Tuberculosis
- Trial name
- NEXT (NCT02454205)
- Testing
- Linezolid, Bedaquiline, Levofloxacin
- Where
- South Africa
- Volunteers
- 154 people
- Sponsor
- University of Cape Town
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
Economic Evaluation of New MDR TB Regimens
The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs.
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- PRACTECAL-EE (NCT04207112)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 7 sites in Belarus, South Africa and 1 more
- Volunteers
- 73 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
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, 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
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, 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 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-resistant Tuberculosis, Extensively Drug-resistant Tuberculosis
Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients
Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as…
- Trial name
- NCT01521364
- Testing
- Addition of different doses of clarithromycin.
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- University Medical Center Groningen
Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB…
- Conditions
- Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- TB-PRACTECAL (NCT02589782)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 7 sites in Belarus, South Africa and 1 more
- Volunteers
- 552 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Adherence, Patient
Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study
The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital…
- Trial name
- PRAXIS (NCT04032730)
- Testing
- Wisepill device
- Where
- South Africa
- Volunteers
- 171 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Multi-drug Resistant Tuberculosis
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
India has the highest incidence of and mortality from multi-drug resistant tuberculosis (MDR-TB) globally. Vitamin D status may be an important determinant of MDR-TB infection and treatment outcomes; however, observational…
- Trial name
- NCT04342598
- Testing
- Serum Vitamin D
- Where
- India
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Tuberculosis
Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
The purpose of this is a study to provide early access of TMC207 to patients with pulmonary infection due to strains of Mycobacterium tuberculosis (M.
- Trial name
- NCT01464762
- Testing
- TMC207
- Where
- 5 sites in Lithuania, Russia
- Sponsor
- Janssen Infectious Diseases BVBA
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
Patient Non-compliance
Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa
The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.
- Trial name
- PRAXIS (NCT03162107)
- Where
- South Africa
- Volunteers
- 199 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa