Clinical trials: Tuberculosis, MDR
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
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
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
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
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
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
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, 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, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
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, 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, 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)
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
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