Clinical trials: Drug Resistant Tuberculosis
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)
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, 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
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.
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
Pulmonary and Extra- Pulmonary Tuberculosis (TB)
Study About Drug Resistance of Mycobacterium Tuberculosis
Tuberculosis is a major cause of ill health and one of the leading causes of death worldwide. Early, rapid and accurate diagnosis of all TB patients and prompt treatment with any form of drug-susceptible or drug resistant TB is…
- Trial name
- NCT07169149
- Where
- Egypt
- Volunteers
- 250 people
- Sponsor
- Sohag University
Tuberculosis
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
- Trial name
- NC-005 (NCT02193776)
- Testing
- PA-824, bedaquiline, moxifloxacin
- Where
- 10 sites in South Africa, Tanzania and 1 more
- Volunteers
- 240 people
- Sponsor
- Global Alliance for TB Drug Development
Drug-resistant Tuberculosis
Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis
A randomized, open, drug controlled design of experiments was used to evaluate the early bactericidal activity, safety, tolerance and pharmacokinetic characteristics of JDB0131 benzenesulfonate tablet taken orally by drug…
- Trial name
- NCT06224036
- Testing
- JDB0131, Delamanid, Ethylpyrazine rifampicide (II)
- Where
- 2 sites in China
- Volunteers
- 52 people
- Sponsor
- Beijing Chest Hospital
Multidrug-resistant Tuberculosis, Extensively Drug-resistant Tuberculosis
Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients
Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as…
- Trial name
- NCT01521364
- Testing
- Addition of different doses of clarithromycin.
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- University Medical Center Groningen
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
Pulmonary Tuberculosis Without Resistance to Rifampicin
Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
The current standard short-course treatment for pulmonary TB requires 6 months to complete. This long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-TB drugs.
- Trial name
- NCT01994460
- Testing
- Linezolid, Ethambutol
- Where
- 3 sites in South Korea
- Volunteers
- 429 people
- Sponsor
- Seoul National University Hospital