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

NCT ID: NCT01853982

Last Updated: 2018-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-14

Study Completion Date

2013-12-08

Brief Summary

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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 .

Detailed Description

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Conditions

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Ventilator-Associated Pneumonia (VAP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ceftolozane/Tazobactam

Intervention Type DRUG

Piperacillin/Tazobactam

4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days

Group Type ACTIVE_COMPARATOR

Piperacillin/Tazobactam

Intervention Type DRUG

Interventions

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Ceftolozane/Tazobactam

Intervention Type DRUG

Piperacillin/Tazobactam

Intervention Type DRUG

Other Intervention Names

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Zosyn

Eligibility Criteria

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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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Obiamiwe Umeh, MD

Role: STUDY_DIRECTOR

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

Locations

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Jacksonville, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Baltimore, Maryland, United States

Site Status

Duluth, Minnesota, United States

Site Status

Omaha, Nebraska, United States

Site Status

Jamaica, New York, United States

Site Status

The Bronx, New York, United States

Site Status

Cleveland, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Abington, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

Site Status

Herston, Queensland, Australia

Site Status

Meadowbrook, Queensland, Australia

Site Status

Nambour, Queensland, Australia

Site Status

Southport, Queensland, Australia

Site Status

Woolloongabba, Queensland, Australia

Site Status

Auckland, , New Zealand

Site Status

Christchurch, , New Zealand

Site Status

Wellington, , New Zealand

Site Status

Countries

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United States Australia New Zealand

Other Identifiers

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CXA-NP-11-08

Identifier Type: OTHER

Identifier Source: secondary_id

7625A-009

Identifier Type: -

Identifier Source: org_study_id

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