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

NCT ID: NCT06168734

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-12-31

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.

Conditions

Ventilator-associated Pneumonia; Hospital-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cefepime-taniborbactam

cefepime-taniborbactam (2g/0.5g) IV every 8 hours.

Group Type: EXPERIMENTAL

Cefepime-taniborbactam

Intervention Type: DRUG

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.

Meropenem

Comparator: meropenem (2g) IV every 8 hours.

Group Type: ACTIVE_COMPARATOR

Meropenem

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Venatorx Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2022-502682-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VNRX-5133-301

Identifier Type: -

Identifier Source: org_study_id