Clinical trials: Multidrug-resistant Tuberculosis
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, 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
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
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, Multidrug-Resistant, HIV
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
This is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (Peru…
- Trial name
- STEM-TB (NCT05871489)
- Testing
- Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months), Bdq, Lzd, Lfx, Cfz, Cs (9-12 months), Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
- Where
- 3 sites in Kazakhstan, Lesotho and 1 more
- Volunteers
- 800 people
- Sponsor
- Harvard Medical School (HMS and HSDM)
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, 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, 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
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, Pulmonary, Tuberculosis, Multidrug-Resistant
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- ZeNix (NCT03086486)
- Testing
- Pretomanid, Linezolid, Bedaquiline
- Where
- 11 sites in Georgia, Moldova and 2 more
- Volunteers
- 181 people
- Sponsor
- Global Alliance for TB Drug Development
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
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
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
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
Rewards for Tuberculosis Contact Screening
This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and…
- Trial name
- RECON (NCT02234908)
- Testing
- Contacts, Index
- Where
- 2 sites in South Africa
- Volunteers
- 301 people
- Sponsor
- Boston University
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 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, 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
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.