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

NCT06168734 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: VNRX-5133-3012022-502682-16
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Ventilated Pneumonia; Hospital Acquired Pneumonia; Bacterial Pneumonia; VABP; vHABP

Outcome Measures

Primary Outcomes (1)

• ACM through Study Day 14

  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.

  Evaluated on Day 15

Secondary Outcomes (2)

• ACM through Study Day 28

  Evaluated on Day 29-33

• Safety Outcomes

  From first dose up to Day 33

Study Arms (2)

Cefepime-taniborbactam

EXPERIMENTAL

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

Drug: Cefepime-taniborbactam

Meropenem

ACTIVE COMPARATOR

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

Drug: Meropenem

Interventions

Cefepime-taniborbactam 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.

Cefepime-taniborbactam

Meropenem 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.

Meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• Have at least one of the following clinical criteria:
• 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).
• 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.

You may not qualify if:

• 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:
• 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
• 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.

Sponsors & Collaborators

• Venatorx Pharmaceuticals, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Pneumonia, Bacterial

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double-blind design is used to maintain blinding for all personnel involved with the evaluation of patient efficacy and safety during the study. With the exception of the unblinded pharmacist or designee, unblinded study monitors and scientists conducting plasma assays and analyses for PK assessments, the sponsor, investigator, patient, and study site staff, will remain blinded to study drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 13, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share