Clinical trials: Drug-resistant Tuberculosis
MDR-TB, Tuberculosis Multi Drug Resistant Active
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
The FAST-MDR trial is an externally-controlled, multicentre trial with one prospective arm, evaluating the non-inferiority of the effectiveness of BPaLM in the interventional arm versus the effectiveness of the long, conventional…
- Conditions
- MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis
- Trial name
- FAST-MDR (NCT07486024)
- Testing
- Bedaquiline Oral Tablet
- Where
- 5 sites in France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
Training Protocol on the Natural History of Tuberculosis
Background: Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.
- Conditions
- Mycobacterium Infections, Tuberculosis, Multidrug-Resistant, Latent Tuberculosis, Tuberculosis
- Trial name
- NCT01212003
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- NCT03338621
- Testing
- Pretomanid, Bedaquiline, Moxifloxacin
- Where
- 26 sites in Brazil, Georgia and 6 more
- Volunteers
- 455 people
- Sponsor
- Global Alliance for TB Drug Development
Multi-drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
- Trial name
- LiMiT (NCT00664313)
- Testing
- Linezolid
- Where
- South Africa
- Volunteers
- 36 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis, Drug-resistant Tuberculosis
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Adherence, Medication, Adherence, Patient
- Trial name
- NCT03266003
- Testing
- Electronic DOT, In-person DOT
- Where
- 4 sites in United States
- Volunteers
- 216 people
- Sponsor
- Centers for Disease Control and Prevention
Multi Drug Resistant Tuberculosis, HIV Infections
An Adaptive Randomized Controlled Trial
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment…
- Trial name
- ADAP-TIV (NCT05633056)
- Testing
- Adherence support intevention
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Linezolid, Tuberculosis Multi Drug Resistant Active
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023.
- Conditions
- Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM)
- Trial name
- PLOT-TB (NCT07477119)
- Testing
- Linezolid dose personalization based on TDM
- Where
- Guinea
- Volunteers
- 150 people
- Sponsor
- Marco Schiuma
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
Multi-drug Resistant Tuberculosis
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
- Trial name
- TB-MR (NCT03057756)
- Testing
- Km+ Mfx+ Pto + H + Cfz +E+Z
- Where
- Gabon
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
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
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
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, 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
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