Clinical trials: Multidrug-Resistant Tuberculosis
Tuberculosis, Drug-resistant Tuberculosis
Brief Bactericidal Activity of Anti-Tuberculosis Drugs
The investigators will determine the bactericidal activity of high-dose isoniazid against M. tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at 0.1 and 0.4 mcg/ml or (2) susceptible at 0.4…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Isoniazid Resistant Tuberculosis (Disorder)
- Trial name
- BBA (NCT02236078)
- Testing
- High dose isoniazid
- Where
- India
- Volunteers
- 18 people
- Sponsor
- Centers for Disease Control and Prevention
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, Multidrug-Resistant
Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru
The objective of this study is to compare the effects of a web-based laboratory information system (e-Chasqui) between a network of health establishments with access to e-Chasqui (intervention group) and a network of health…
- Trial name
- NCT01201941
- Testing
- e-Chasqui
- Where
- Peru
- Volunteers
- 1,849 people
- Sponsor
- Brigham and Women's Hospital
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
Tuberculosis, Pulmonary, Mycobacterium Tuberculous
Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali
Background: -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate.
- Conditions
- Tuberculosis, Pulmonary, Mycobacterium Tuberculous, Antitubercular Agents, Tuberculosis, Mulutidrug-Resistant
- Trial name
- NCT01381757
- Where
- 2 sites in United States, Mali
- Volunteers
- 34 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Pre-XDR-TB
Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care
BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid…
- Conditions
- Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04062201
- Testing
- Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form
- Where
- 2 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Wits Health Consortium (Pty) Ltd
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR
- Trial name
- PRISM-TB (NCT06441006)
- Testing
- Bedaquiline, Linezolid, Pretomanid
- Where
- 6 sites in Mongolia, Pakistan and 3 more
- Volunteers
- 400 people
- Sponsor
- University of California, San Francisco
Tuberculosis, Multidrug-Resistant
Expand New Drugs for TB [endTB]
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB.
- Trial name
- NCT03259269
- Testing
- This is a non-intervention observational study
- Where
- 16 sites in Armenia, Bangladesh and 12 more
- Volunteers
- 2,804 people
- Sponsor
- Partners in Health
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
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
Tuberculosis, Multidrug-Resistant
Hotspots, Households and Hospitals: Enhanced Drug-resistant Tuberculosis Case Finding in Namibia
Poor case management, pharmacokinetic variability and on-going transmission have fostered the drug-resistant tuberculosis (DR-TB) epidemic leading to a global estimated number of >500,000 new multidrug resistant (MDR) TB cases…
- Trial name
- H3TB (NCT05022238)
- Where
- Namibia
- Volunteers
- 2,100 people
- Sponsor
- University of Namibia
Tuberculosis, HIV
DNA Sequencing of MDR TB in Eastern Siberia
This is protocol is generated in response to the exploratory R21 from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) for US-Russia collaborative research in HIV/tuberculosis…
- Trial name
- NCT02508610
- Where
- Russia
- Volunteers
- 630 people
- Sponsor
- University of Virginia
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
Tuberculosis, Multidrug-Resistant
DIAgnostics for Multidrug Resistant Tuberculosis in Africa
Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin…
- Trial name
- DIAMA (NCT03303963)
- Testing
- Deeplex test, MolBio TrueNat for 2nd line, GeneXpert 2nd line, Fluorescein DiAcetate (FDA) Microscopy,GeneXpert Ct value, pre-rRNA synthesis
- Where
- 10 sites in Belgium, Benin and 8 more
- Volunteers
- 3,356 people
- Sponsor
- Dissou AFFOLABI
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.
MDR-TB, HIV
A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs.
- Trial name
- NCT02129244
- Testing
- NCM-Plus
- Where
- 15 sites in South Africa
- Volunteers
- 2,844 people
- Sponsor
- Johns Hopkins University
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
Rifampicin-Resistant Tuberculosis
A 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis
This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa.
- Trial name
- MDR-ENDPlus (NCT07675954)
- Testing
- MDR-END Plus regimen, Standard-of-care (SoC) treatment
- Where
- 2 sites in South Africa
- Volunteers
- 294 people
- Sponsor
- Seoul National University Hospital
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
Tuberculosis, Tuberculosis, Multidrug-Resistant
Global Consortium for Drug-resistant Tuberculosis Diagnostics
The goal of this study is to evaluate time to diagnosis for three assays (line probe, pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect resistance to first and second-line anti-tuberculosis…
- Trial name
- GCDD (NCT02170441)
- Where
- 3 sites in India, Moldova and 1 more
- Volunteers
- 1,128 people
- Sponsor
- University of California, San Diego