A Phase 3 Study to Evaluate Cefepime-taniborbactam Compared to Meropenem in Adults With Ventilator Associated Bacterial Pneumonia (VABP) or Ventilated Hospital Acquired Bacterial Pneumonia (vHABP)

VNRX-5133-301

This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.

2024-10-01

2027-03-01

2027-09-01

Not yet recruiting

Early phase I

316

Inclusion Criteria: * Male or female, ≥18 years of age. * The patient or patient's legally authorized/acceptable representative (LAR) has voluntarily signed and dated the IRB/IEC approved ICF * Meets the clinical diagnosis of ventilated HABP or VABP * Have at least one of the following clinical criteria: 1. New onset or worsening of pulmonary symptoms and signs 2. New onset or worsening of purulent respiratory secretions 3. Hypoxemia 4. Need for acute changes in ventilator support * Have at least one of the following clinical criteria: 1. Documented fever (defined as body temperature ≥ 38°C \[100.4°F\] 2. Hypothermia (defined as body temperature ≤ 35°C \[95°F\]) 3. White blood cell (WBC) ≥10,000 cells/mm3 or ≤4,500 cells/mm3 4. \>15% immature neutrophils (bands). * Have new or worsening infiltrate on a pulmonary imaging study that is consistent with bacterial pneumonia within 48 hours prior to randomization. * Have a lower respiratory tract specimen sent for Gram stain and quantitative culture within 36 hours prior to the first dose of study drug. Exclusion Criteria: * Receipt of effective antibacterial treatment for pneumonia for a continuous duration of \>24 hours during the previous 72 hours prior to randomization. * Pneumonia known or suspected to be caused by: 1. A bacterial pathogen resistant to meropenem, as assessed by susceptibility testing or against which either one or both study drugs lack activity 2. Viruses, atypical bacteria, or fungi * Use of non-study systemic gram-negative therapy. * Confounding respiratory conditions. * Receiving extracorporeal membrane oxygenation (ECMO). * Patients with refractory septic shock. * Active immunosuppression. * Has a history of serious hypersensitivity (e.g., anaphylaxis), serious allergy, or any serious reaction to cephalosporin, penicillin, carbapenem, or other β-lactam antibiotics. * Female patients who are pregnant. * Patients with eGFR \<10 mL/min/1.73 m2 or are receiving or starting renal replacement therapy or expected to require renal replacement therapy during the treatment phase of the study.

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2024-04-24