Clinical trials: Drug-resistant Tuberculosis
TB Multi-drug Resistant
Dose Escalation Study of SQ109 in Healthy Adult Volunteers
The purposes of this study are to determine: how safe it is to take SQ109 (an experimental tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how well the body accepts it; how SQ109 enters and…
- Trial name
- NCT00866190
- Testing
- SQ109
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, MDR
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance.
- Trial name
- FS-1 (NCT02607449)
- Testing
- FS-1
- Where
- 6 sites in Kazakhstan, Kyrgyzstan
- Volunteers
- 344 people
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
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
Tuberculosis, Multidrug-Resistant
The Individualized M(X) Drug-resistant TB Treatment Strategy Study
This is a randomized controlled clinical trial comparing treatment success of a gene-derived individualized drug-resistant Tuberculosis regimen to a standard Tuberculosis regimen based on South African National Tuberculosis…
- Trial name
- InDEX (NCT03237182)
- Testing
- Individualized TB treatment with multiple drugs, Standardized TB treatment with multiple drugs
- Where
- South Africa
- Volunteers
- 205 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Tuberculosis, Drug-resistant Tuberculosis
Evaluation of Centralised TB Assay Solutions
Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB.
- Trial name
- NCT04147676
- Where
- 6 sites in Georgia, Germany and 3 more
- Volunteers
- 1,050 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Pulmonary Tuberculosis
Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.
- Trial name
- NCT01498419
- Testing
- Moxifloxacin (M), Pretomid (Pa), Pyrazinamide (Z)
- Where
- 8 sites in South Africa, Tanzania
- Volunteers
- 207 people
- Sponsor
- Global Alliance for TB Drug Development
Multi Drug Resistant Tuberculosis, HIV Infections
An Adaptive Randomized Controlled Trial
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment…
- Trial name
- ADAP-TIV (NCT05633056)
- Testing
- Adherence support intevention
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Tuberculosis, Tuberculosis, Multidrug-Resistant
Tuberculosis in China
Background: In spite of well-researched treatments and therapies, 5 to 10 percent of tuberculosis (TB) patients who have initially successful TB treatments will relapse, usually within a year after completion of therapy.
- Conditions
- Tuberculosis, Tuberculosis, Multidrug-Resistant, Extensively Drug Resistant Tuberculosis
- Trial name
- NCT01071603
- Where
- China
- Volunteers
- 199 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Multi Drug Resistant Active
Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin
The proposed study will randomize adults (18 years of age or older) with pulmonary MDR-TB with sputum that contains M. tuberculosis that is isoniazid and rifampin resistant by MTBDRplus and fluoroquinolone susceptible by MTBDRsl…
- Trial name
- DAZZLE (NCT02975570)
- Testing
- Delamanid, Linezolid, Levofloxacin
- Sponsor
- Boston University
Tuberculosis, Adherence, Patient
Behavior Change and Digital Health Interventions for Improved TB Treatment Outcomes
Each year, 10.4 million patients are diagnosed with and 1.7 million people die from Tuberculosis (TB). Despite the availability of highly effective and accessible medications in the developing world where TB is endemic, the 6-18…
- Conditions
- Tuberculosis, Adherence, Patient, Adherence, Medication, Drug-resistant Tuberculosis
- Trial name
- NCT04119375
- Testing
- Keheala Mobile Health Platform and Behavioral Interventions, Social and Behavior Change Communication (SBCC), SMS Reminder
- Where
- Kenya
- Volunteers
- 16,146 people
- Sponsor
- Massachusetts Institute of Technology
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
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
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
Tuberculosis, Multi Drug Resistant, Strains
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.
- Conditions
- Tuberculosis, Multi Drug Resistant, Strains, Molecular Epidemiology, Multi Drug Resistant Tuberculosis
- Trial name
- MESTCAR (NCT07017803)
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Multidrug Resistant Tuberculosis
Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide
Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge to TB control program. That pyrazinamide can shorten the course of treatment and facilitate bacilli clearance has been proved recently.
- Trial name
- NCT02120638
- Testing
- Pyrazinamide containing regimen, Regimen without Pyrazinamide
- Where
- 11 sites in China
- Volunteers
- 100 people
- Sponsor
- Huashan Hospital
Multi-drug Resistant Tuberculosis
PK of Levofloxacin in MDR-TB Patients
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at…
- Trial name
- NCT03000517
- Where
- Nepal
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
Tuberculosis, Multidrug Resistant Tuberculosis
An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional…
- Conditions
- Tuberculosis, Multidrug Resistant Tuberculosis, Extensively-drug Resistant Tuberculosis
- Trial name
- NEXT (NCT02454205)
- Testing
- Linezolid, Bedaquiline, Levofloxacin
- Where
- South Africa
- Volunteers
- 154 people
- Sponsor
- University of Cape Town
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