Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

Forest Laboratories680 enrolled

Overview

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

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

680

Conditions

Bacterial Infections

Interventions

ceftarolineDRUG

600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

vancomycin plus aztreonamDRUG

vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.

PlaceboDRUG

Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease. Exclusion Criteria: * Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial. * Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

Locations (54)

Outcomes

Primary Outcomes

Clinical Cure Rate at Test of Cure (TOC) (MITT Population)

Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome

Time frame: 8-15 days after last dose of study drug administration

The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.

Time frame: 8-15 days after last dose of study drug

Secondary Outcomes

To Evaluate the Microbiological Success Rate at the TOC Visit

Time frame: 8-15 days after the last dose of study drug

To Evaluate the Clinical Response at the End of Therapy (EOT) Visit

Time frame: last day of study drug administration

To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit

Time frame: 8-15 days after last dose of study drug

To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit

Time frame: 21 to 35 days after the last dose of study drug

To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit

Time frame: 21-35 days after last dose of study drug

Data from ClinicalTrials.gov

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Investigational Site

Buena Park, California, United States

Investigational Site

Hawaiian Gardens, California, United States

Investigational Site

Los Angeles, California, United States

Investigational Site

Pasadena, California, United States

Investigational Site

San Diego, California, United States

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San Jose, California, United States

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Atlantis, Florida, United States

Investigational Site

Columbus, Georgia, United States

Investigational Site

Marietta, Georgia, United States

Investigational Site

Springfield, Illinois, United States

...and 44 more locations