WithdrawnPhase 3

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

Stopped: Study suspended

0Started 2025-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. New onset or worsening of pulmonary symptoms and signs
✓. New onset or worsening of purulent respiratory secretions
✓. Hypoxemia
✓. Need for acute changes in ventilator support
✓. Documented fever (defined as body temperature ≥ 38°C \[100.4°F\]
✓. Hypothermia (defined as body temperature ≤ 35°C \[95°F\])
✓. White blood cell (WBC) ≥10,000 cells/mm3 or ≤4,500 cells/mm3
✓. \>15% immature neutrophils (bands).

Exclusion criteria

✕. A bacterial pathogen resistant to meropenem, as assessed by susceptibility testing or against which either one or both study drugs lack activity
✕. Viruses, atypical bacteria, or fungi

What they're measuring

ACM through Study Day 14

Timeframe: Evaluated on Day 15

Trial details

NCT IDNCT06168734

SponsorVenatorx Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Ventilator-associated Pneumonia trials