Back to resultsStudy of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Primary Purpose
Ventilator-Associated Pneumonia (VAP)
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceftolozane/Tazobactam
Piperacillin/Tazobactam
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator-Associated Pneumonia (VAP)
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ceftolozane/Tazobactam
Piperacillin/Tazobactam
Arm Description
3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
Outcomes
Primary Outcome Measures
Clinical Response at the End of Therapy Visit
Secondary Outcome Measures
Full Information
NCT ID
NCT01853982
First Posted
May 13, 2013
Last Updated
October 18, 2018
Sponsor
Cubist Pharmaceuticals LLC
1. Study Identification
Unique Protocol Identification Number
NCT01853982
Brief Title
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Terminated to focus on a larger study within the clinical development program.
Study Start Date
June 14, 2013 (Actual)
Primary Completion Date
November 20, 2013 (Actual)
Study Completion Date
December 8, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Associated Pneumonia (VAP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftolozane/Tazobactam
Arm Type
Experimental
Arm Description
3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
Arm Title
Piperacillin/Tazobactam
Arm Type
Active Comparator
Arm Description
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
Intervention Type
Drug
Intervention Name(s)
Ceftolozane/Tazobactam
Intervention Type
Drug
Intervention Name(s)
Piperacillin/Tazobactam
Other Intervention Name(s)
Zosyn
Primary Outcome Measure Information:
Title
Clinical Response at the End of Therapy Visit
Time Frame
24 hours after last dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Obiamiwe Umeh, MD
Organizational Affiliation
Cubist Pharmaceuticals LLC
Official's Role
Study Director
Facility Information:
City
Jacksonville
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Duluth
State/Province
Minnesota
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Jamaica
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Abington
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Herston
State/Province
Queensland
Country
Australia
City
Meadowbrook
State/Province
Queensland
Country
Australia
City
Nambour
State/Province
Queensland
Country
Australia
City
Southport
State/Province
Queensland
Country
Australia
City
Woolloongabba
State/Province
Queensland
Country
Australia
City
Auckland
Country
New Zealand
City
Christchurch
Country
New Zealand
City
Wellington
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
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