Clinical trials: Tuberculosis, Multidrug-Resistant, open to volunteers
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.
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, 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 Tuberculosis
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with…
- Trial name
- TEDITUB (NCT05534750)
- Testing
- Tedizolid arm (SIVEXTRO®), Linezolid arm (ZYVOXID®), Standard quadruple therapy arm
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Multidrug- and Rifampicin-resistant Tuberculosis
BPaL(M) Regimen for the Treatment of MDR/RR-TB
The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid, Linezolid for 26 weeks for the treatment of MDR/RR-TB…
- Trial name
- NCT05381194
- Testing
- BPaL(M) regimen
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Asan Medical Center
Multidrug-resistant Tuberculosis (MDR-TB)
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.
- Trial name
- MESTCAR (NCT07017803)
- Where
- 8 sites in Gabon
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Rifampin-resistant Tuberculosis, Drug-resistant Tuberculosis
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with…
- Trial name
- THERMOL (NCT06590428)
- Testing
- Therapeutic Drug Monitoring for Linezolid
- Where
- South Africa
- Volunteers
- 280 people
- Sponsor
- Albert Einstein College of Medicine
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
Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis
Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course…
- Conditions
- Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis, MDR-TB, RR-TB
- Trial name
- AHA-PLUS (NCT07393438)
- Testing
- Acetohydroxamic Acid
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Tuberculosis, Multidrug-Resistant
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
- Trial name
- NCT06674291
- Testing
- No intervention (observational study)
- Volunteers
- 222 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
MDR-TB, Tuberculosis Multi Drug Resistant Active
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
The FAST-MDR trial is an externally-controlled, multicentre trial with one prospective arm, evaluating the non-inferiority of the effectiveness of BPaLM in the interventional arm versus the effectiveness of the long, conventional…
- Conditions
- MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis
- Trial name
- FAST-MDR (NCT07486024)
- Testing
- Bedaquiline Oral Tablet
- Where
- 5 sites in France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
Tuberculosis, Multidrug-Resistant
Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis
Resistance to anti-tuberculosis drugs is a continually growing problem. Multidrug-resistant tuberculosis (MDRTB) is resistance to at least rifampicin and isoniazid, and extensively drug-resistant TB is additional resistance to a…
- Trial name
- T3-RCT (NCT05007795)
- Testing
- Targeted sequencing using the GenoScreen Deeplex assay
- Where
- South Africa
- Volunteers
- 280 people
- Sponsor
- University of Cape Town
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
Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis
Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort
The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older.
- Conditions
- Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Drug-resistant Tuberculosis
- Trial name
- INSPIRE-BLMZ (NCT07268664)
- Testing
- BLMZ
- Where
- 3 sites in China
- Volunteers
- 120 people
- Sponsor
- Beijing Chest Hospital
MDR-TB, Immunotherapy
A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB
A Exploratory Study of drug combination (zoledronic acid/interleukin 2) that specifically amplifies Vγ2Vδ2 T cells in combination with anti-tuberculosis chemotherapy for the treatment of MDR-TB.
- Trial name
- NCT05493267
- Testing
- Vγ2Vδ2 T lymphocyte-based immunotherapy, Treatment regimens for MDR-TB
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
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
Treat to Target, Treatment Duration
6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province
This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen…
- Trial name
- BDLL (NCT07198685)
- Testing
- bedaquiline, Delamanid (DLM), Linezolid (LZD)
- Volunteers
- 52 people
- Sponsor
- Wuhan Pulmonary Hospital
Tuberculosis, Multidrug-Resistant
Bioneer Q-RFIA Clinical Evaluation
Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both…
- Trial name
- NCT05117788
- Testing
- Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac
- Where
- 5 sites in Kenya, Moldova and 3 more
- Volunteers
- 2,350 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland