Clinical Research Directory

Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

This is a Phase 3, randomized, double-blind, multicenter, comparative study evaluating cefepime-zidebactam (FEP-ZID) versus ceftazidime-avibactam (CAZ-AVI) with or without colistin in the treatment of adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Trial participants will be randomized in a 1:1 ratio to receive either FEP-ZID or CAZ-AVI with or without colistin for 7 to 14 days. Colistin will be added to the CAZ-AVI regimen (or matching saline to the FEP-ZID regimen, to maintain blinding) for participants with a baseline pathogen presumed or confirmed to be CAZ-AVI-resistant. All trial participants will also receive linezolid for coverage of methicillin-resistant staphylococci for at least the first 3 days of treatment. The primary objectives are to assess 14-day all-cause mortality between treatment groups and to assess the safety and tolerability of FEP-ZID relative to CAZ-AVI with or without colistin. Secondary objectives include 28-day all-cause mortality, clinical and microbiological outcomes at End-of-Treatment (EOT) and Test-of-Cure (TOC), sustained clinical cure at Late Follow-up (LFU), superinfection and new infection rates, and pharmacokinetic (PK) characterization of FEP and ZID.

Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP

This study aims to evaluate the effect of ventilator hyperinflation combined with body positioning on arterial blood gases in patients with ventilator-associated pneumonia. Forty-two mechanically ventilated patients will be randomly assigned into two groups receiving the intervention in either supine or lateral decubitus positions. Arterial blood gases will be assessed over a 6-day intervention period. The findings are expected to provide evidence regarding the optimal positioning strategy to enhance the effectiveness of ventilator hyperinflation in improving gas exchange in critically ill patients.

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 to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). Part B is the single-group portion of the study and includes patients with HABP or VABP with CRABC infections that are resistant to or have failed colistin/polymyxin B treatment.

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. The study is divided into two parts (Part A and Part B), recruiting in parallel. Approximately 10 subjects will be recruited in Part B, with enrollment ending once Part A enrollment is complete (at least 30 patients randomized to all of the three groups). Eligible patients, who have given informed consent, will be enrolled, and pre-treatment microbiology samples submitted to a local laboratory.