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

Tracking Information

First Received Date ^ICMJE

January 16, 2007

Last Updated Date

July 23, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

cure rate of ceftaroline treatment compared with that of vancomycin plus aztreonam [ Time Frame: Test-of-Cure (TOC) visit ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

non-inferiority in clinical cure rate [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00424190 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the microbiological success rate [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
Evaluate the clinical response [ Time Frame: End-of-Therapy visit ] [ Designated as safety issue: No ]
Evaluate the clinical and microbiological response by pathogen [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
Evaluate clinical relapse [ Time Frame: Late Follow-up (LFU) visit ] [ Designated as safety issue: No ]
Evaluate microbiological reinfection or recurrence [ Time Frame: LFU visit ] [ Designated as safety issue: No ]
Evaluate safety [ Time Frame: throughout the dosing period and up to the TOC visit ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

microbiological success rate [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bacterial Infections

Intervention ^ICMJE

Drug: vancomycin plus aztreonam
Drug: Ceftaroline

Study Arms / Comparison Groups

Experimental: Ceftaroline for Injection

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

703

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Chile, Germany, Mexico, Peru, Poland, Romania, Russian Federation, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00424190

Responsible Party

Senior Vice President, Clinical Development, Cerexa, Inc

Study ID Numbers ^ICMJE

P903-06

Study Sponsor ^ICMJE

Cerexa, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Ralph Corey, MD

Duke University

Information Provided By

Cerexa, Inc.

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP