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

Phase 3

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: IV Vancomycin plus IV Aztreonam; Drug: Ceftaroline

• Registration Number: NCT00424190
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-18
• Study Start: 2007-02
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2010-10-12
• Results First Submitted QC: 2010-10-12
• Results First Posted: 2010-11-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 698

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Vancomycin and IV Aztreonam	IV Vancomycin plus IV Aztreonam	-
Ceftaroline for Injection	Ceftaroline	-

Primary Outcome Measures

Name	Time	Method
Clinical Cure Rate at Test of Cure (TOC) (MITT Population)	8-15 days after the end of treatment	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 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
Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population	8-15 days after last dose of study drug

Secondary Outcome Measures

Name	Time	Method
Microbiological Success Rate at the TOC Visit	8-15 days after last dose of study drug
Clinical Relapse at the Late Follow Up (LFU) Visit	21 to 35 days after the last dose of study drug
Microbiological Reinfection or Recurrence at the LFU Visit	21 to 35 days after the last dose of study drug
Assess Safety	First dose of study drug through TOC visit	Comparisons of the number of participants with Adverse Events
Clinical and Microbiological Response by Pathogen at the TOC Visit	8-15 days after last dose of study drug
Clinical Response at the End of Therapy (EOT) Visit	Last day of study drug administration

Trial Locations

Locations (2)

Investigational Site; 🇺🇦 Lviv, Ukraine

Invetigational Site; 🇵🇪 Lima, Peru