A Multicenter, Randomized, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of ASK0912 for Injection Versus Polymyxin B for Injection in Adult Patients With Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia
This is a randomized, active-controlled, multicenter phase II clinical trial. The study aims to evaluate the efficacy, safety and tolerability of two different dosing regimens of ASK0912 for Injection compared with Polymyxin B Sulfate for Injection in adult patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by multidrug-resistant or carbapenem-resistant Gram-negative bacilli. Eligible subjects will be randomly assigned to one of three treatment groups: ASK0912 Regimen 1, ASK0912 Regimen 2, or Polymyxin B Sulfate active comparator group. Subjects will receive assigned intravenous study treatment for 7 to 14 days. The primary efficacy endpoints include clinical cure rate at the Test of Cure (TOC) visit and Day 28 all-cause mortality in the modified intent-to-treat (MITT) population. Safety assessments will be conducted throughout the study to monitor adverse events, laboratory parameters and other safety indicators.
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria
A Clinical Study of YK-1169 Versus Ceftazidime-Avibactam in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
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
Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.
Comparison of Epithelial Lining Fluid and Blood Pharmacokinetics and Pharmacodynamics of Intravenous and Intravenous Plus Nebulized Polymyxin B in Multidrug Resistant Bacteria Ventilator-associated Pneumonia Patients