Clinical trials: Drug-resistant Tuberculosis
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)
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.
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
Self-verification and Support Via Mobile Phones Drastically Improves Tuberculosis Treatment Success in LMIC Settings
Each year, 10.4 million patients are diagnosed with and 1.8 million people die from Tuberculosis (TB). Despite the availability of highly effective and accessible medications in the developing world where TB is endemic, the 6-18…
- Trial name
- NCT03135366
- Testing
- Keheala, Standard of Care
- Volunteers
- 1,190 people
- Sponsor
- Yale University
Pulmonary Multi-drug Resistant Tuberculosis
A Prospective Patient Registry of Patients Exposed to Bedaquiline
The purpose of this study is to describe the medical indication and utilization of expert medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility based on minimum inhibitory concentrations…
- Trial name
- NCT02274389
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Janssen Research & Development, LLC
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
MDR Tuberculosis, Resistance to Tuberculostatic Drugs
Artificial Inteligent for Diagnosing Drug-Resistant Tuberculosis
Title: Artificial Neural Network as Diagnostic Tools For Rifampicin-Resistant Tuberculosis In Indonesia. A Predictive Model Study and Economic Evaluation.
- Trial name
- NCT04208789
- Testing
- Rapid Molecular Drug-Resistant Tuberculosis Test, Artificial Intelligent Model, Drug Susceptibility Test
- Where
- 5 sites in Indonesia
- Volunteers
- 524 people
- Sponsor
- Hasanuddin University
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
Tuberculosis, Adherence, Patient
Behavior Change and Digital Health Interventions for Improved TB Treatment Outcomes
Each year, 10.4 million patients are diagnosed with and 1.7 million people die from Tuberculosis (TB). Despite the availability of highly effective and accessible medications in the developing world where TB is endemic, the 6-18…
- Conditions
- Tuberculosis, Adherence, Patient, Adherence, Medication, Drug-resistant Tuberculosis
- Trial name
- NCT04119375
- Testing
- Keheala Mobile Health Platform and Behavioral Interventions, Social and Behavior Change Communication (SBCC), SMS Reminder
- Where
- Kenya
- Volunteers
- 16,146 people
- Sponsor
- Massachusetts Institute of Technology
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, 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
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
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
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains
Bone Resistant Tuberculosis
The recommendations for the treatment of MDR tuberculosis are based on pulmonary tuberculosis since there is a lack of specific recommendations for TB bone and osteoarticular disease, including those due to multi drug resistance…
- Trial name
- TboneR (NCT04928378)
- Testing
- Descriptive retrospective study
- Where
- France
- Volunteers
- 23 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HIV Infections, Tuberculosis
A Registry of Tuberculosis Cases in the CPCRA
PRIMARY: To estimate the proportion of tuberculosis patients in the CPCRA who have drug-resistant tuberculosis (TB) and to describe the patterns of drug resistance.
- Trial name
- NCT00000785
- Where
- 13 sites in United States
- Volunteers
- 1,509 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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, Multidrug-Resistant
Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less…
- Trial name
- NCT02354014
- Testing
- Bedaquiline (TMC207), Background Regimen (BR)
- Where
- 11 sites in Mozambique, Philippines and 4 more
- Volunteers
- 60 people
- Sponsor
- Janssen Research & Development, LLC
Multi-drug Resistant Tuberculosis
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
PandrTB is a study of the pharmacokinetics(PK) and pharmacodynamics(PD) of bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin, levofloxacin and pyrazinamide used in novel combinations to treat multidrug-resistant…
- Trial name
- PandrTB (NCT03827811)
- Where
- 7 sites in Kazakhstan, Lesotho and 4 more
- Volunteers
- 625 people
- Sponsor
- University of Cape Town
TB Multi-drug Resistant
Epidemiology of MDR-TB in Peru
The purpose of this study is to better understand tuberculosis (TB) and the risk of infection with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets in the air that come from the lungs of an…
- Trial name
- Estudio Epi (NCT00676754)
- Testing
- Statens Serum Institut RT23 2TU tuberculin
- Where
- Peru
- Volunteers
- 18,544 people, healthy volunteers welcome
- Sponsor
- Harvard University Faculty of Medicine