Clinical trials: Multidrug-Resistant Tuberculosis
MDR-TB
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing.
- Trial name
- STREAM (NCT02409290)
- Testing
- Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine
- Where
- 13 sites in Ethiopia, Georgia and 5 more
- Volunteers
- 588 people
- Sponsor
- IUATLD, Inc
Multi-drug Resistant Tuberculosis
PK of Levofloxacin in MDR-TB Patients
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at…
- Trial name
- NCT03000517
- Where
- Nepal
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
Treat to Target, Treatment Duration
6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province
This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen…
- Trial name
- BDLL (NCT07198685)
- Testing
- bedaquiline, Delamanid (DLM), Linezolid (LZD)
- Volunteers
- 52 people
- Sponsor
- Wuhan Pulmonary Hospital
Tuberculosis, Multidrug-Resistant
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around the world. This type of tuberculosis is very difficult to treat, and many patients die from it.
- Trial name
- Opti-Q (NCT01918397)
- Testing
- Levofloxacin, Optimized background regimen (OBR)
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 111 people
- Sponsor
- Boston University
Multi-drug Resistant Tuberculosis
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
- Trial name
- NCT03470233
- Where
- 2 sites in South Korea
- Volunteers
- 149 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
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
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
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
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
Tuberculosis Infection
Intensifying Multi-Drug Resistant Tuberculosis Contact Tracing by Social Network Analysis
Tuberculosis burden in Vietnam increasing with contribution from low detection rates and increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant Tuberculosis) among both notified TB cases and their…
- Trial name
- SNAP (NCT02175849)
- Where
- Vietnam
- Volunteers
- 596 people
- Sponsor
- Oxford University Clinical Research Unit, Vietnam
Tuberculosis
Multidrug Resistance in Newly Diagnosed TB Patient
Tuberculosis (TB) is one of the major public health threats, competing with the human immunodeficiency virus (HIV) as the cause of death due to infectious diseases worldwide.
- Trial name
- NCT06700577
- Testing
- Gene expert, Ultra xpert and xdr xpert
- Volunteers
- 100 people
- Sponsor
- Assiut University
Tuberculosis, Multidrug-Resistant
Clinical Evaluation of tNGS for Diagnosis of DR-TB
Current rapid molecular assays for detection of drug-resistant TB from direct clinical samples have important limitations. They are not suited for high-throughput settings; can only be used to detect a limited number of target…
- Trial name
- Seq&Treat (NCT04239326)
- Testing
- targeted Next Generation Sequencing (tNGS)
- Where
- 3 sites in Georgia, India and 1 more
- Volunteers
- 800 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Tuberculosis, Multidrug Resistant
Drug Concentrations in the Treatment of MDR-TB Related to Minimum Inhibitory Concentrations
Multi-drug resistant tuberculosis (MDR-TB) is steadily increasing world-wide, urging for the need of improved treatment strategies.
- Trial name
- TDM-MDR-TB (NCT02816931)
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Karolinska Institutet
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis
PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Bacterial Infections, Mycobacterial Infection
- Trial name
- NCT04783727
- Testing
- Individualised treatment duration based on RNA transcriptomic model
- Where
- 5 sites in Germany, Moldova and 2 more
- Volunteers
- 4 people
- Sponsor
- Research Center Borstel