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

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ClinicalTrials.gov Identifier: NCT01853982
Recruitment Status : Terminated (Terminated to focus on a larger study within the clinical development program.)
First Posted : May 15, 2013
Results First Posted : June 15, 2015
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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 .

Condition or disease Intervention/treatment Phase
Ventilator-Associated Pneumonia (VAP) Drug: Ceftolozane/Tazobactam Drug: Piperacillin/Tazobactam Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 14, 2013
Actual Primary Completion Date : November 20, 2013
Actual Study Completion Date : December 8, 2013


Arm Intervention/treatment
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
Drug: Ceftolozane/Tazobactam
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
Drug: Piperacillin/Tazobactam
Other Name: Zosyn




Primary Outcome Measures :
  1. Clinical Response at the End of Therapy Visit [ Time Frame: 24 hours after last dose of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853982


Locations
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United States, Florida
Jacksonville, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Minnesota
Duluth, Minnesota, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
Bronx, New York, United States
Jamaica, New York, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Abington, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
Australia, Queensland
Herston, Queensland, Australia
Meadowbrook, Queensland, Australia
Nambour, Queensland, Australia
Southport, Queensland, Australia
Woolloongabba, Queensland, Australia
New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Wellington, New Zealand
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
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Study Director: Obiamiwe Umeh, MD Cubist Pharmaceuticals LLC
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Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01853982    
Other Study ID Numbers: 7625A-009
CXA-NP-11-08 ( Other Identifier: Cubist Study Number )
First Posted: May 15, 2013    Key Record Dates
Results First Posted: June 15, 2015
Last Update Posted: November 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Ceftolozane
Ceftolozane, tazobactam drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents