Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP

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)

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.

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.