Clinical trials: Tuberculosis, Multidrug-Resistant
Tuberculosis
TB Immunotherapy Trial With Heat-killed M. Vaccae
The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and…
- Trial name
- imm03 (NCT01977768)
- Testing
- V7
- Where
- 2 sites in Mongolia, Ukraine
- Volunteers
- 152 people
- Sponsor
- Immunitor LLC
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
Multidrug Resistant Tuberculosis
NGS-Guided(G) Regimens(R) of Anti-tuberculosis(A) Drugs for the Control(C) and Eradication(E) of MDR-TB
Tuberculosis (TB) has been one of the top 10 causes of death worldwide from a single infectious agent, ranking above HIV/AIDS. Management and eradication of this disease is being hindered by the emergence of multidrug-resistant…
- Trial name
- GRACE-TB (NCT03604848)
- Testing
- WHO-approved MDR-TB regimen, NGS-guided regimen: Regimen A, NGS-guided regimen: Regimen B
- Where
- 12 sites in China
- Volunteers
- 488 people
- Sponsor
- Huashan Hospital
Latent Tuberculosis
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
- Trial name
- NCT02454738
- Testing
- Ultralow dose chest CT scan
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
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, 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)
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
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
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
Pulmonary Tuberculosis
The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)
The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary…
- Trial name
- NCT06476210
- Testing
- BDL regimen
- Where
- 7 sites in China
- Volunteers
- 45 people
- Sponsor
- Beijing Chest Hospital
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
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
Drug Resistant Tuberculosis, MDR-TB
Triage Test for All Oral DR-TB Regimen (TRiAD Study)
A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB-A multi-centre, multi-country…
- Conditions
- Drug Resistant Tuberculosis, MDR-TB, XDR-TB, Tuberculosis
- Trial name
- NCT05175794
- Testing
- Xpert® MTB/XDR
- Where
- 4 sites in Ethiopia, Nigeria and 1 more
- Volunteers
- 786 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Drug Resistant Tuberculosis
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
The goal of the BringBPaL2Me Trial, a multi-principal investigator, multi-site, cluster randomized, non-inferiority trial is to compare nurse-led RR-TB treatment in primary care clinics to standard of care physician-led RR-TB…
- Trial name
- NCT05671718
- Testing
- Nurse-Led Treatment in Primary Care
- Where
- 5 sites in South Africa
- Volunteers
- 2,944 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Drug-resistant Tuberculosis
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Adherence, Medication, Adherence, Patient
- Trial name
- NCT03266003
- Testing
- Electronic DOT, In-person DOT
- Where
- 4 sites in United States
- Volunteers
- 216 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis, HIV Infections
Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
This study evaluated the safety, tolerability, and pharmacokinetics of the anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination, among participants (with or without HIV co-infection) taking…
- Trial name
- NCT02583048
- Testing
- Bedaquiline, Delamanid, Dolutegravir
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 84 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multi Drug Resistant Tuberculosis
Evaluation of PCR Using DNA Extract From Slides and Filter Paper for the Detection of Tuberculosis and MDR-tuberculosis
Specimen transport from peripheral health structures to the National TB reference laboratory for MDR-TB identification presents a big challenge in term of sample management, safety, contamination and delays.
- Trial name
- NCT03137875
- Where
- Uganda
- Volunteers
- 122 people
- Sponsor
- Epicentre
Tuberculosis
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
Multi-drug Resistant Tuberculosis
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
India has the highest incidence of and mortality from multi-drug resistant tuberculosis (MDR-TB) globally. Vitamin D status may be an important determinant of MDR-TB infection and treatment outcomes; however, observational…
- Trial name
- NCT04342598
- Testing
- Serum Vitamin D
- Where
- India
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)