Ventilator-associated PneumoniaPhase 3CERTAIN-2NCT06168734
Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP
A Phase 3 study testing Cefepime-taniborbactam and Meropenem in people with Ventilator-associated Pneumonia and Hospital-acquired Pneumonia, run by Venatorx Pharmaceuticals, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia, Hospital-acquired Pneumonia
- What is being tested?
- Cefepime-taniborbactam and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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)
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.
- Being tested
- Cefepime-taniborbactam, Meropenem
- Keywords
- Ventilated Pneumonia, Hospital Acquired Pneumonia, Bacterial Pneumonia, VABP, vHABP
- Medical subject headings
- Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefepime-taniborbactamDrug
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.
MeropenemDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cefepime-taniborbactam | Experimental | cefepime-taniborbactam (2g/0.5g) IV every 8 hours. Receives: Drug: Cefepime-taniborbactam |
| Meropenem | Active comparator | Comparator: meropenem (2g) IV every 8 hours. Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated on Day 15
Secondary outcomes (2)
ACM through Study Day 28
ACM through Study Day 28; analyzed in ITT and MITT analysis populations.
Measured: Evaluated on Day 29-33
Safety Outcomes
Safety assessments include the incidence of TEAEs and SAEs, and discontinuation of study drug due to TEAEs.
Measured: From first dose up to Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Study suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168734
- Sponsor's protocol ID
- VNRX-5133-301
- Other IDs
- 2022-502682-16
- Acronym
- CERTAIN-2
- Status last verified
- Jun 2025
- First submitted
- 4 Dec 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06168734
- Acronym / sponsor ID
- CERTAIN-2 / VNRX-5133-301
- Keywords
- Ventilated Pneumonia, Hospital Acquired Pneumonia, Bacterial Pneumonia, VABP, vHABP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study suspended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cefepime-taniborbactam | Experimental | Drug: Cefepime-taniborbactamcefepime-taniborbactam (2g/0.5g) IV every 8 hours. |
| Meropenem | Active comparator | Drug: MeropenemComparator: meropenem (2g) IV every 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Have at least one of the following clinical criteria:
Key exclusion criteria (12 listed)
- 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:
- Use of non-study systemic gram-negative therapy.
- Confounding respiratory conditions.
- Receiving extracorporeal membrane oxygenation (ECMO).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefepime-taniborbactamCefepime-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. | Drug | Cefepime-taniborbactam |
| MeropenemMeropenem 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. | Drug | Meropenem |
Primary outcome
ACM through Study Day 14
Time frame: Evaluated on Day 15
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.
2 secondary outcomes
ACM through Study Day 28
Time frame: Evaluated on Day 29-33
Safety Outcomes
Time frame: From first dose up to Day 33
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefepime-taniborbactam and Meropenem in people with Ventilator-associated Pneumonia and Hospital-acquired Pneumonia, run by Venatorx Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACM through Study Day 14 (time frame: Evaluated on Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.