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

  • 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
  • United States
    • Florida
      • Jacksonville, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Minnesota
      • Duluth, Minnesota, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Bronx, New York, United States
      • Jamaica, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States

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
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 Names:
  • Zosyn

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cubist Pharmaceuticals LLC

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

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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