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

Sponsor:	Cerexa, Inc.
Information provided by:	Cerexa, Inc.
ClinicalTrials.gov Identifier:	NCT00424190

Purpose

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

Condition	Intervention	Phase
Bacterial Infections	Drug: IV Vancomycin plus IV Aztreonam Drug: Ceftaroline	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bacterial Infections Skin Conditions Skin Infections

Drug Information available for: Aztreonam Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

Clinical Cure Rate at Test of Cure (MITT Population) [ Time Frame: 8-15 days after the end of treatment ] [ Designated as safety issue: No ]
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 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 [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological Success Rate at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
Clinical Response at the End of Therapy (EOT) Visit [ Time Frame: Last day of study drug administration ] [ Designated as safety issue: No ]
Clinical and Microbiological Response by Pathogen at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
Clinical Relapse at the Late Follow Up (LFU) Visit [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
Microbiological Reinfection or Recurrence at the LFU Visit [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
Assess Safety [ Time Frame: First dose of study drug through TOC visit ] [ Designated as safety issue: No ]
Comparisons of the number of participants with Adverse Events

Enrollment:	698
Study Start Date:	February 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ceftaroline for Injection	Drug: Ceftaroline 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days Other Name: Experimental
Active Comparator: IV Vancomycin and IV Aztreonam	Drug: IV Vancomycin plus IV Aztreonam 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. Other Name: Active Comparator

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424190

Show 52 Study Locations

Sponsors and Collaborators

Cerexa, Inc.

Investigators

Principal Investigator:

Ralph Corey, MD

Duke University

More Information

No publications provided by Cerexa, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Corey GR, Wilcox MH, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 1 investigators. CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv41-51.

Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50.

Responsible Party:	Senior Vice President, Clinical Development, Cerexa, Inc
ClinicalTrials.gov Identifier:	NCT00424190 History of Changes
Other Study ID Numbers:	P903-06
Study First Received:	January 16, 2007
Results First Received:	October 12, 2010
Last Updated:	November 23, 2010
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Italy: National Bioethics Committee; Italy: Ministry of Health; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Poland: Ministry of Health; Switzerland: Ethikkommission; Switzerland: Swissmedic; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Argentina: Human Research Bioethics Committee; Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health; Brazil: National Health Surveillance Agency; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Chile: Instituto de Salud Publica de Chile; Mexico: Ethics Committee; Mexico: Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; Peru: Ethics Committee; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Peru: Ministry of Health; Romania: National Medicines Agency; Romania: State Institute for Drug Control; Russia: Ethics Committee; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Cerexa, Inc.:

Abscess
Antibacterial
Antibiotic
Antimicrobial
Bacterial infection, skin
Ceftaroline
Ceftaroline acetate
Cellulitis
Cephalosporin
Complicated skin and skin structure infection
cSSSI

Intravenous
MRSA
PPI-0903
Prodrug
Skin disease, bacterial
Skin infection
Staphylococcal skin infection
Staphylococcus aureus
Streptococcal skin infection
Surgical site infection
TAK-599

Additional relevant MeSH terms:

Bacterial Infections
Skin Diseases, Infectious
Infection
Skin Diseases
Aztreonam

Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012