Clinical trials: Drug-Resistant Tuberculosis
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
Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV
Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter in Ukraine. After many years of laboratory and clinical testing the formulation was approved in 1997 by the Ministry of Health of Ukraine…
- Trial name
- NCT01061593
- Testing
- Immunoxel
- Where
- 2 sites in Mongolia, Ukraine
- Volunteers
- 269 people
- Sponsor
- Lisichansk Regional Tuberculosis Dispensary
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
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB)…
- Trial name
- NCT02365623
- Testing
- TMC207 (bedaquiline), Background Regimen (BR)
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Janssen Pharmaceutical K.K.
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.
Respiratory Tract Infections, Corona Virus Infection
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment.
- Trial name
- NCT03331445
- Testing
- Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- Chris Miller
Pulmonary Tuberculosis
Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for…
- Trial name
- NCT05359315
- Testing
- Interferon-Gamma
- Where
- Russia
- Volunteers
- 84 people
- Sponsor
- SPP Pharmaclon Ltd.
Latent Tuberculosis, Staphylococcus Aureus
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Two commonly used treatments for latent tuberculosis infection are either 4 months rifampicin or 6-9 months isoniazid. The invistigators will study the risk of acquisition of rifampicin resistance in commensal Staphylococcus…
- Trial name
- NCT05073926
- Testing
- No intervention is part of the study protocol
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Region Skane
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
Tuberculosis, Resistance Bacterial
TB-CAPT MTB/XDR Study
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and…
- Conditions
- Tuberculosis, Resistance Bacterial, Diagnoses Disease
- Trial name
- NCT04567368
- Testing
- Xpert MTB/XDR
- Where
- 2 sites in South Africa
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
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
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
Pulmonary Disease, Tuberculosis, Pulmonary
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to…
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04493671
- Testing
- TBAJ-876 suspension, TBAJ-876 100 mg tablet, TBAJ-876 25 mg tablet
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Multi-drug Resistant Tuberculosis
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
- Trial name
- NCT04309656
- Testing
- Pretomanid
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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
Safety and Efficacy of Oral Immunomodulator in Tuberculosis (TB) and TB/HIV Patients
Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24 months) and more toxic treatment course.
- Trial name
- NCT01222338
- Testing
- V-5 immunitor
- Where
- Ukraine
- Volunteers
- 123 people
- Sponsor
- Lisichansk Regional Tuberculosis Dispensary
Tuberculosis
High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Isoniazid (INH) is a drug commonly used to treat tuberculosis (TB) worldwide. Sometimes, the bacteria that cause TB can become resistant to INH.
- Trial name
- NCT01936831
- Testing
- Isoniazid, Vitamin B6
- Where
- 2 sites in Haiti, South Africa
- Volunteers
- 282 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Mycobacterium Tuberculosis
Rapid Characterization of Paucibacillary TB Along Tex/Mex Border
This study will test a method of detecting tuberculosis-causing bacteria that are resistant to current medication treatments. Blood samples will be collected from patients from 3 sites and 3 mainly Hispanic populations in Texas…
- Trial name
- NCT00421798
- Where
- 3 sites in United States, Colombia and 1 more
- Volunteers
- 780 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
Feasibility and Accuracy of a Novel Xpert Cartridge
Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens.
- Trial name
- (XpertDST) (NCT02251327)
- Testing
- Investigational Xpert DST test
- Volunteers
- 401 people
- Sponsor
- Johns Hopkins University