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Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infection

Intervention: ceftaroline (Drug); linezolid (Drug); Aztreonam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Medical Monitor Cerexa, Study Director, Affiliation: Forest Laboratories

Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

Clinical Details

Official title: A Phase 2, Multicenter, Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population

Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population

Secondary outcome:

Clinical Cure Rate at the TOC Visit in the cMITT Population

Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.

The Microbiological Response at the TOC Visit in the mMITT and ME Populations.

Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations

Clinical Relapse at the Late Follow-up Visit

The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit

The Safety of Ceftaroline Fosamil

Detailed description: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.

Eligibility

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

Criteria:

Inclusion Criteria:

- Complicated skin and skin structure infection (cSSSI)

- Require initial hospitalization, or treatment in an emergency room or urgent care

setting Exclusion Criteria:

- Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid,

aztreonam, or to their components

- Concomitant use of adrenergic or serotonergic agent

- Uncomplicated skin and skin structure infection

- Concomitant therapy with any drug known to exhibit a contraindicated drug-drug

interaction

- More than 24 hours of treatment with an antimicrobial within 96 hours before

randomization

- Known or suspected endocarditis, osteomyelitis, or septic arthritis

- Severely impaired renal function

- Evidence of significant hepatic, hematologic, or immunologic disease

Locations and Contacts

Investigational Site, Buena Park, California 96020, United States

Investigational Site, Long Beach, California 90813, United States

Investigational Site, Los Angeles, California 90015, United States

Investigational Site, Rolling Hills Estate, California 90274, United States

Investigational Site, San Diego, California 92114, United States

Investigational Site, Atlantis, Florida 33462, United States

Investigational Site, Columbus, Georgia 31904, United States

Investigational Site, Savannah, Georgia 31405, United States

Investigational Site, Minneapolis, Minnesota 55422, United States

Investigational Site, Butte, Montana 59701, United States

Investigational Site, Somers Point, New Jersey 08244, United States

Investigational Site, Columbus, Ohio 43215, United States

Investigational Site, Toledo, Ohio 43608, United States

Additional Information

Starting date: February 2008
Last updated: October 9, 2012

Page last updated: August 23, 2015

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