Clinical trials: Resistance Bacterial
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bacterial Pneumonia
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
- Trial name
- ATTAIN2 (NCT00124020)
- Testing
- Telavancin, Vancomycin
- Where
- Israel
- Volunteers
- 771 people
- Sponsor
- Cumberland Pharmaceuticals
Bacterial Infections
Children's Antibiotic Resistant Infections in Low Income Countries
The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal and childhood bacterial infections in low-income countries,in particular those caused by antibiotic resistant bacteria.
- Trial name
- ChARLI (NCT02074865)
- Testing
- biological samples
- Where
- Madagascar
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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
Wound Infection
Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients
The central aim of this trial is to investigate the safety and tolerability of Phage Cocktail-SPK as an adjunct to standard therapy for the prevention and treatment of burns susceptible to infection/or infected by S. aureus, P.
- Trial name
- NCT04323475
- Testing
- Bacteriophage cocktail spray, Xeroform
- Volunteers
- 12 people
- Sponsor
- Precisio Biotix Therapeutics, Inc.
Bacterial Infections
Study of Debio 1450 for Bacterial Skin Infections
The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal…
- Trial name
- NCT02426918
- Testing
- Debio 1450 IV, Debio 1450 Oral, Linezolid
- Where
- 22 sites in United States
- Volunteers
- 330 people
- Sponsor
- Debiopharm International SA
Gram-Positive Bacterial Infections, Staphylococcus Infections
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.
- Conditions
- Gram-Positive Bacterial Infections, Staphylococcus Infections, Vancomycin Resistance, Methicillin Resistance
- Trial name
- NCT00079976
- Testing
- Tigecycline
- Volunteers
- 174 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Urinary Tract Infection Complicated, Acute Pyelonephritis
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02168946
- Testing
- Vabomere, Best Available Therapy
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 77 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI)
- Trial name
- NCT07089186
- Testing
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Drug Resistance, Bacterial, Antimicrobial Drug Resistance
Fecal Microbiota Transplantation (FMT) to Decolonize Antibiotic - Resistant Bacteria (ARB) - New Protocol
The aim of the study is to assess the safety and efficacy of new protocol fecal microbiota transplantation (FMT) in the eradication of antibiotic resistant bacteria, including those featuring of resistance to new generation…
- Trial name
- STOP-ARB2 (NCT06156956)
- Testing
- Fecal Microbiota Transplantation
- Where
- 5 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Human Biome S.A.
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections.
- Conditions
- Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP), Blood Stream Infection, Meningitis, Bacterial
- Trial name
- RIV- CARE (NCT07431307)
- Testing
- BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT)
- Volunteers
- 120 people
- Sponsor
- BioVersys AG
Ventilator Associated Pneumonia
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
A multicenter Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B in adult patients with VABP suspected or confirmed to be due to CRAB
- Trial name
- NCT05685615
- Testing
- BV100 plus Polymyxin B, BAT
- Where
- 16 sites in Georgia, Greece and 1 more
- Volunteers
- 39 people
- Sponsor
- BioVersys AG
Vulvovaginal Candidiases, Yeast Infection
Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).
- Conditions
- Vulvovaginal Candidiases, Yeast Infection, Vulvovaginitis, Yeast Infection Vaginal
- Trial name
- NCT03167957
- Testing
- Oral Encochleated Amphotericin B (CAMB)
- Where
- United States
- Sponsor
- Matinas BioPharma Nanotechnologies, Inc.
Bacterial Pneumonia
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
- Trial name
- ATTAIN1 (NCT00107952)
- Testing
- Telavancin, Vancomycin
- Where
- United States
- Volunteers
- 761 people
- Sponsor
- Cumberland Pharmaceuticals
Infections, Bacterial
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830
A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled, dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3342830 after administration of…
- Trial name
- NCT02751424
- Testing
- GSK3342830
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
E Coli Infections, Allogenic Transplant Patients
Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant
This is a Phase 1b/2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC…
- Trial name
- NCT06938867
- Testing
- SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
- Where
- 10 sites in United States
- Volunteers
- 66 people
- Sponsor
- SNIPR Biome Aps.
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
This is a two-part study, with Part A being the randomized, controlled portion of the study in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) suspected or confirmed…
- Conditions
- Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP), Colistin Resistanrt ABC, Acinetobacter Baumannii-calcoaceticus Complex
- Trial name
- RIV-TARGET (NCT07326540)
- Testing
- BV100 (300 mg), Polymyxin B, Colistin
- Where
- Georgia
- Volunteers
- 248 people
- Sponsor
- BioVersys SAS
Multidrug-resistant Tuberculosis
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.
- Trial name
- NCT01424670
- Testing
- Delamanid + OBR
- Where
- 17 sites in Estonia, Latvia and 5 more
- Volunteers
- 511 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Gram-Negative Bacterial Infections
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae…
- Trial name
- NCT00079989
- Testing
- tigecycline
- Volunteers
- 115 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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.