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

Ventilator-associated Pneumonia Clinical Trial

— CERTAIN-2  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06168734
• Other study ID #: VNRX-5133-301
• Secondary ID: 2022-502682-16
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2024
• Est. completion date: September 2027

Study information

• Verified date: April 2024
• Source: Venatorx Pharmaceuticals, Inc.
• Contact: Venatorx
• Phone: 610-644-8935
• Email: vnrxclinsci[@]venatorx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 316
• Est. completion date: September 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Hospital-acquired Pneumonia
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Venatorx Pharmaceuticals, Inc.	Biomedical Advanced Research and Development Authority

Outcome

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