Clinical trial NCT00633152: Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Infection
Keywords: complicated skin and skin structure infections
linezolid
ceftaroline
clinical response
microbiological response
Cellulitis
Abscess
Wound infection
Deeper soft tissue
Significant surgical intervention
Gram-positive bacterial infection
Gram-negative bacterial infection
bacterial infection
cephalosporin
broad-spectrum activity
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population
timeFrame: Test of Cure Visit (8 to 15 days after end of therapy)
measure: Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population
timeFrame: Test of Cure Visit (8 to 15 Days after end of therapy)
Secondary outcomes:
measure: Clinical Cure Rate at the TOC Visit in the cMITT Population
timeFrame: TOC Visit (8 to 15 days after end of therapy)
measure: Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.
timeFrame: End-of-therapy (EOT) visit
measure: The Microbiological Response at the TOC Visit in the mMITT and ME Populations.
timeFrame: TOC Visit (8 to 15 days after end of therapy)
measure: Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations
timeFrame: TOC Visit (8 to 15 days after end of therapy)
measure: Clinical Relapse at the Late Follow-up Visit
timeFrame: Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)
measure: The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit
timeFrame: LFU Visit (21 to 35 days after end of therapy)
measure: The Safety of Ceftaroline Fosamil
timeFrame: First dose of study drug through LFU Visit or 30 days after the last dose of study drug
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: Investigational Site
state: California
city: Long Beach
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Rolling Hills Estate
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Atlantis
country: United States
facility: Investigational Site
state: Florida
city: Columbus
country: United States
facility: Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Investigational Site
state: Georgia
city: Minneapolis
country: United States
facility: Investigational Site
state: Minnesota
city: Butte
country: United States
facility: Investigational Site
state: Montana
city: Somers Point
country: United States
facility: Investigational Site
state: New Jersey
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Investigational Site
state: Ohio
Study officials:
affiliation: Forest Laboratories
name: Medical Monitor Cerexa
role: STUDY_DIRECTOR
References: