Cefepime-taniborbactam Vs Meropenem in Adults with VABP or Ventilated HABP

Phase 3

Withdrawn

• Conditions: Ventilator-associated Pneumonia; Hospital-acquired Pneumonia
• Interventions: Drug: Cefepime-taniborbactam; Drug: Meropenem

• Registration Number: NCT06168734
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-13
• Status Verified: 2024-10
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Start: 2025-06
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefepime-taniborbactam	Cefepime-taniborbactam	cefepime-taniborbactam (2g/0.5g) IV every 8 hours.
Meropenem	Meropenem	Comparator: meropenem (2g) IV every 8 hours.

Primary Outcome Measures

Name	Time	Method
ACM through Study Day 14	Evaluated on Day 15	The primary endpoint is ACM, a binary variable, through Study Day 14. The primary endpoint is evaluated in the ITT population and is based on the patient's survival status through Study Day 14.

Secondary Outcome Measures

Name	Time	Method
ACM through Study Day 28	Evaluated on Day 29-33	ACM through Study Day 28; analyzed in ITT and MITT analysis populations.
Safety Outcomes	From first dose up to Day 33	Safety assessments include the incidence of TEAEs and SAEs, and discontinuation of study drug due to TEAEs.