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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
First received
Last updated
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
Health authority
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.

Study Design


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
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