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

Forest Laboratories150 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Bacterial Infection

Interventions

ceftarolineDRUG

600 mg injected every 12 hours for at least 5 but not more than 14 days

linezolidDRUG

600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days

AztreonamDRUG

1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (13)

Investigational Site

Buena Park, California, United States

Investigational Site

Long Beach, California, United States

Investigational Site

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.

Time frame: Test of Cure Visit (8 to 15 days after end of therapy)

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

The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.

Time frame: Test of Cure Visit (8 to 15 Days after end of therapy)

Secondary Outcomes

Clinical Cure Rate at the TOC Visit in the cMITT Population

Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.

Time frame: TOC Visit (8 to 15 days after end of therapy)

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

Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.

Time frame: End-of-therapy (EOT) visit

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

Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.

Data from ClinicalTrials.gov

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