- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853982
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
October 18, 2018 updated by: Cubist Pharmaceuticals LLC
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
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 .
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Herston, Queensland, Australia
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Meadowbrook, Queensland, Australia
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Nambour, Queensland, Australia
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Southport, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Auckland, New Zealand
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Christchurch, New Zealand
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Wellington, New Zealand
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Florida
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Jacksonville, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Maryland
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Baltimore, Maryland, United States
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Minnesota
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Duluth, Minnesota, United States
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Nebraska
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Omaha, Nebraska, United States
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New York
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Bronx, New York, United States
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Jamaica, New York, United States
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Ohio
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Cleveland, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Pennsylvania
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Abington, Pennsylvania, United States
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Tennessee
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Nashville, Tennessee, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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:
- History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
- Known end stage renal disease or requirement for dialysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ceftolozane/Tazobactam
3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
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Active Comparator: Piperacillin/Tazobactam
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Clinical Response at the End of Therapy Visit
Time Frame: 24 hours after last dose of study drug
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24 hours after last dose of study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Obiamiwe Umeh, MD, Cubist Pharmaceuticals LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2013
Primary Completion (Actual)
November 20, 2013
Study Completion (Actual)
December 8, 2013
Study Registration Dates
First Submitted
May 13, 2013
First Submitted That Met QC Criteria
May 13, 2013
First Posted (Estimate)
May 15, 2013
Study Record Updates
Last Update Posted (Actual)
November 16, 2018
Last Update Submitted That Met QC Criteria
October 18, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Cross Infection
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Pneumonia
- Pneumonia, Ventilator-Associated
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Piperacillin
- Tazobactam
- Piperacillin, Tazobactam Drug Combination
- Ceftolozane
- Ceftolozane, tazobactam drug combination
Other Study ID Numbers
- 7625A-009
- CXA-NP-11-08 (Other Identifier: Cubist Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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