Status:

TERMINATED

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

Lead Sponsor:

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

Conditions:

Ventilator-Associated Pneumonia (VAP)

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • Key
  • 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

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

Key Trial Info

Start Date :

June 14 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 8 2013

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT01853982

Start Date

June 14 2013

End Date

December 8 2013

Last Update

November 16 2018

Active Locations (19)

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Page 1 of 5 (19 locations)

1

Jacksonville, Florida, United States

2

Chicago, Illinois, United States

3

Baltimore, Maryland, United States

4

Duluth, Minnesota, United States