Clinical trials: Drug Resistance, Multiple, Bacterial
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
PRACTECAL-PKPD Sub Study
PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and…
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis
- Trial name
- PRACTECAL-PKPD (NCT04081077)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 5 sites in Belarus, South Africa
- Volunteers
- 240 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Drug Resistance, Multiple, Bacterial Infections
Prediction of Multidrug-resistant Bacterial Infection in Patients with Cirrhosis
The aim of this study is to identify predictive factors of infections caused by multidrug-resistant organisms in patients with cirrhosis and to develop and validate (internally and externally) a predictive model that might be…
- Conditions
- Drug Resistance, Multiple, Bacterial Infections, Liver Cirrhosis
- Trial name
- NCT05641025
- Where
- Argentina
- Volunteers
- 1,774 people
- Sponsor
- Hospital Italiano de Buenos Aires
Intestinal Multi-drug Resistant Organism Colonization
Further MT for Antibiotic-Resistant Bacterial Colonization
The purpose of this study is to better understand the effectiveness and safety of microbiome therapies (MT) as a treatment for patients with Multidrug Resistant Organism (MDRO) colonization after an infection.
- Trial name
- FAIR (NCT05835206)
- Testing
- Microbiome Therapeutic
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Emory 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
Pulmonary Tuberculosis
A PAN-USR TB Multi-Center Trial
Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide.
- Trial name
- NCT06905522
- Testing
- Bedaquiline (B), Sitafloxacin (S), Linezolid (L)
- Where
- 3 sites in China
- Volunteers
- 610 people
- Sponsor
- Shenzhen Third People's Hospital
Multi-drug Resistant Tuberculosis
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
- Trial name
- NCT01600963
- Testing
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Where
- 44 sites in Brazil, Cambodia and 15 more
- Sponsor
- Janssen Infectious Diseases BVBA
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
Bacterial Resistance, Infection Resistant to Multiple Drugs
SATURN 04 Nosocomial Acquisition Study
The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6 medical wards will participate in the study.
- Conditions
- Bacterial Resistance, Infection Resistant to Multiple Drugs, Staph Aureus Methicillin Resistant Colonization, Infection Due to ESBL Bacteria
- Trial name
- SATURN (NCT01208519)
- Where
- 3 sites in Italy, Romania and 1 more
- Volunteers
- 16,680 people
- Sponsor
- Catholic University of the Sacred Heart
Multi-drug Resistant Tuberculosis
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
Brief summary: Allogeneic γδT cells from healthy donor will be administrated intravenously to patients with the MDR-TB，and then the safety and efficacy of γδT cells will be evaluated.
- Trial name
- MDR-TB (NCT03575299)
- Testing
- The adoptive treatment of allogeneic γδT cells, Control, Conventional treatment
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Zhinan Yin, Ph.D.
Tuberculosis, Pre-XDR-TB
Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care
BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid…
- Conditions
- Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04062201
- Testing
- Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form
- Where
- 2 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Wits Health Consortium (Pty) Ltd
Drug Resistance, Bacterial
Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes.
This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.
- Trial name
- R'EHPAD (NCT03248999)
- Testing
- rectal swab
- Where
- France
- Volunteers
- 264 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
Shortening Treatment by Advancing Novel Drugs
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with…
- Trial name
- STAND (NCT02342886)
- Testing
- Moxifloxacin, PA-824, Pyrazinamide
- Where
- 26 sites in Georgia, Kenya and 6 more
- Volunteers
- 284 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary Disease, Tuberculosis, Pulmonary
A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT05526911
- Testing
- TBAJ-876, Midazolam, Digoxin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Multi-drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
- Trial name
- LiMiT (NCT00664313)
- Testing
- Linezolid
- Where
- South Africa
- Volunteers
- 36 people
- Sponsor
- Centers for Disease Control and Prevention
Multiresistant Bacterial Pathogens, Virulent Bacterial Pathogens
Development of a Swiss Surveillance Database for Molecular Epidemiology of Hypervirulent and Multi-drug Resistant Pathogens
Hypervirulent and multidrug-resistant infections are associated with significant health care costs, substantial morbidity and mortality.
- Trial name
- NCT04172025
- Testing
- Analysis of Bacterial Genome
- Where
- 5 sites in Switzerland
- Volunteers
- 10,000 people
- Sponsor
- University Hospital, Basel, Switzerland
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Multi-Drug Resistant Tuberculosis
Metronidazole for Pulmonary Tuberculosis (South Korea)
This study will evaluate the effect of adding metronidazole to standard second-line therapy for tuberculosis in patients who have multi-drug resistant tuberculosis (MDR-TB) of the lungs.
- Trial name
- NCT00425113
- Testing
- Metronidazole, Blood Draw, CT Scan
- Where
- 2 sites in South Korea
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multidrug-Resistant Gram-Negative Bacterial Infections, Antimicrobial Resistance
The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections
This study evaluates whether adding melatonin to standard colistin therapy improves outcomes in patients with multidrug-resistant (MDR) Gram-negative bacterial infections.
- Trial name
- NCT07503600
- Testing
- Melatonin
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Enterobacteriaceae Infections, Multi-antibiotic Resistance
FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
Antibiotic resistance (AR) is a critical public health threat and one of the greatest challenges of the 21st century. In an estimate of 2019, nearly 700.000 infections and 33.000 attributable deaths from multi-drug-resistant…
- Trial name
- FMT_CRE (NCT05791396)
- Testing
- Donor - FMT
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS