Clinical trial NCT06168734: Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Ventilator-associated Pneumonia
Hospital-acquired Pneumonia
Keywords: Ventilated Pneumonia
Hospital Acquired Pneumonia
Bacterial Pneumonia
VABP
vHABP
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2023-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will randomize approximately 316 patients with vHABP or VABP into 2 groups in a 1:1 ratio (158 patients to cefepime-taniborbactam; 158 patients to meropenem).
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: ACM through Study Day 14
timeFrame: Evaluated on Day 15
Secondary outcomes:
measure: ACM through Study Day 28
timeFrame: Evaluated on Day 29-33
measure: Safety Outcomes
timeFrame: From first dose up to Day 33
Other outcomes:
Locations:
Study officials:
References: