Ventilator-Associated Pneumonia (VAP)Phase 3NCT01853982

Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

A Phase 3 study testing Ceftolozane/Tazobactam and Piperacillin/Tazobactam in people with Ventilator-Associated Pneumonia (VAP), run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 19 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants . Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventilator-Associated Pneumonia (VAP)
What is being tested?: Ceftolozane/Tazobactam and Piperacillin/Tazobactam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 19 sitesin 3 countries
Study dates: 14 Jun 2013to 8 Dec 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participant has received mechanical ventilation for > 48 hours
Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35
Presence of a new or progressive infiltrate on chest x-ray
Presence of clinical criteria consistent with VAP

Who cannot join

History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
Known end stage renal disease or requirement for dialysis

Trial locations and contacts

19 sites in 3 countries.

Country

City, postcode or hospital

19 sites in 3 countries

United States11 sites

Study site
Abington, Pennsylvania
Study site
Baltimore, Maryland
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Duluth, Minnesota
Study site
Jacksonville, Florida
Study site
Jamaica, New York
Study site
Nashville, Tennessee
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
The Bronx, New York

Other trials in United States

Australia5 sites

Study site
Herston, Queensland
Study site
Meadowbrook, Queensland
Study site
Nambour, Queensland
Study site
Southport, Queensland
Study site
Woolloongabba, Queensland

Other trials in Australia

New Zealand3 sites

Study site
Auckland
Study site
Christchurch
Study site
Wellington

Other trials in New Zealand

About this study

Official title: A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam With That of Piperacillin/Tazobactam in Ventilator Associated Pneumonia

Conditions: Ventilator-Associated Pneumonia (VAP)
Being tested: Ceftolozane/Tazobactam, Piperacillin/Tazobactam
Medical subject headings: Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ceftolozane/TazobactamDrug
Piperacillin/TazobactamDrug
Also called Zosyn

Study groups in NCT01853982
Study group	Role	What they receive
Ceftolozane/Tazobactam	Experimental	3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days Receives: Drug: Ceftolozane/Tazobactam
Piperacillin/Tazobactam	Active comparator	4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days Receives: Drug: Piperacillin/Tazobactam

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Response at the End of Therapy Visit
Measured: 24 hours after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 20138 Dec 2013

First posted15 May 2013 (estimated)
Study start14 Jun 2013
Primary completion20 Nov 2013
Study completion8 Dec 2013

Why it stopped: Terminated to focus on a larger study within the clinical development program.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ventilator-Associated Pneumonia (VAP)Studies 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
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01853982
Sponsor's protocol ID: 7625A-009
Other IDs: CXA-NP-11-08
Status last verified: Oct 2018
First submitted: 13 May 2013
Last updated: 16 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)

All Ventilator-Associated Pneumonia (VAP) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam With That of Piperacillin/Tazobactam in Ventilator Associated Pneumonia
ClinicalTrials.gov ID: NCT01853982
Acronym / sponsor ID: 7625A-009
Conditions: Ventilator-Associated Pneumonia (VAP)
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated to focus on a larger study within the clinical development program.
Enrolment: 4 participants (actual)
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 14 Jun 2013 (actual)
Primary completion: 20 Nov 2013 (actual)
Study completion: 8 Dec 2013 (actual)
First posted: 15 May 2013 (estimated)
Results: Posted 15 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ceftolozane/Tazobactam	Experimental	Drug: Ceftolozane/Tazobactam3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
Piperacillin/Tazobactam	Active comparator	Drug: Piperacillin/Tazobactam4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participant has received mechanical ventilation for > 48 hours
Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35
Presence of a new or progressive infiltrate on chest x-ray
Presence of clinical criteria consistent with VAP

Key exclusion criteria (2 listed)

History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
Known end stage renal disease or requirement for dialysis

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
Ceftolozane/Tazobactam	Drug	Ceftolozane/Tazobactam
Piperacillin/TazobactamAlso: Zosyn	Drug	Piperacillin/Tazobactam

Primary outcome

Clinical Response at the End of Therapy Visit
Time frame: 24 hours after last dose of study drug

Results and safety

Results posted to the registry on 15 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ceftolozane/Tazobactam	2	0
Piperacillin/Tazobactam	2	1

Primary outcome: Clinical Response at the End of Therapy Visit

Time frame: 24 hours after last dose of study drug

Population analysed: There is no analysis population or data available for this measure. This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ceftolozane/Tazobactam	1 of 2 (50%)	2 of 2 (100%)	Not reported
Piperacillin/Tazobactam	1 of 2 (50%)	1 of 2 (50%)	Not reported

Limitations and caveats (from the sponsor): This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Ventilator-Associated Pneumonia (VAP)

Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)

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.

Obiamiwe Umeh, MD study director

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

19 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 15 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Response at the End of Therapy Visit (time frame: 24 hours after last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01853982.

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 16 Nov 2018.