NCT06168734

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)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Venatorx Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilator-associated Pneumonia
• Hospital-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Cefepime-taniborbactam	Cefepime-taniborbactam administered 2.5g q8h intravenously (IV) over a 4-hour period for 7 days to 14 days at the investigator's discretion. Dose adjustments for renal function may apply.
DRUG	Meropenem	Meropenem will be administered 2g q8h IV over 4 hours for 7 days to 14 days at the investigator's discretion. Dose adjustments for renal function may apply.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2023-12-13
• Last updated: 2025-06-08

Regulatory

• FDA-regulated drug study