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Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nosocomial Pneumonia

Intervention: ceftolozane/tazobactam (Drug); Meropenem (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cubist Pharmaceuticals Holdings LLC

Official(s) and/or principal investigator(s):
Obiamiwe Umeh, Study Director, Affiliation: Cubist Pharmaceuticals

Overall contact:
Allyson Cygnarowicz, Phone: 919-227-5849, Email: allyson.cygnarowicz@incresearch.com

Summary

This is a Phase 3, Multicenter, Prospective, Randomized study of IV ceftolozane/tazobactam vs. IV meropenem in the treatment of adult patients with either Ventilator-Associated Bacterial Pneumonia [VABP] or Ventilated Hospital-Acquired Bacterial Pneumonia [HABP].

Clinical Details

Official title: A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam Compared With Meropenem in Adult Patients With Ventilated Nosocomial Pneumonia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: All Cause Mortality

Secondary outcome:

Clinical response rates of ceftolozane/tazobactam versus meropenem in adult subjects with VNP in the Microbiological Intent-to-Treat (mITT), Intent-to-Treat (ITT) and the Clinically Evaluable (CE) populations

Clinical response rates at the TOC visit (ceftolozane/tazobactam versus meropenem) in the subset of subjects who had P. aeruginosa from the baseline lower respiratory tract culture

Day 28 all-cause mortality rates of subjects in the ceftolozane/tazobactam versus meropenem arms in the Microbiological Intent-to-Treat (mITT) population

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Inclusion Criteria: 1. Adult patients diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy 2. Hospitalized for ≥ 48 hours, intubated and on mechanical ventilation at the time of randomization; 3. APACHE II score between 15 and 35; 4. New or progressive infiltrate on chest radiography consistent with pneumonia 5. Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial pneumonia Key Exclusion Criteria: 1. History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics 2. Prior nonstudy antibiotics for > 24 hours 3. Gram-positive bacteria only on respiratory Gram stain. 4. Active immunosuppression 5. End-stage renal disease or requirement for dialysis; 6. Expected survival < 72 hours 7. Severe confounding respiratory condition (i. e., chest trauma with paradoxical respiration) 8. Known or suspected community-acquired bacterial pneumonia

Locations and Contacts

Allyson Cygnarowicz, Phone: 919-227-5849, Email: allyson.cygnarowicz@incresearch.com

Fresno, California 93701, United States; Recruiting

Sacramento, California 95817, United States; Recruiting

Torrance, California 90509, United States; Recruiting

Jacksonville, Florida 32209, United States; Recruiting

Chicago, Illinois 60611, United States; Recruiting

Springfield, Illinois 62702, United States; Recruiting

Topeka, Kansas 66606, United States; Recruiting

Hazard, Kentucky 41701, United States; Recruiting

New Orleans, Louisiana 70112, United States; Recruiting

Omaha, Nebraska 68198, United States; Recruiting

Omaha, Nebraska 68131, United States; Recruiting

Las Vegas, Nevada 89109, United States; Recruiting

Bronx, New York 10467, United States; Recruiting

Buffalo, New York 14215, United States; Recruiting

Jamaica, New York 11418, United States; Recruiting

Syracuse, New York 13210, United States; Recruiting

Cleveland, Ohio 44195, United States; Recruiting

Columbia, Ohio 65212, United States; Recruiting

Lima, Ohio 45801, United States; Recruiting

Toledo, Ohio 43614, United States; Recruiting

Additional Information

Starting date: August 2014
Last updated: July 28, 2015

Page last updated: August 23, 2015

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