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

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 3


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: Bacterial Infections Skin Infections

Drug Information available for: Vancomycin Vancomycin hydrochloride Aztreonam Ceftaroline Ceftaroline fosamil

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 52 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators


Principal Investigator:	Ralph Corey, MD	Duke University

More Information

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. doi: 10.1093/jac/dkq254.

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. doi: 10.1086/655827.


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 Pública 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 of the Russian Federation Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Forest Laboratories:


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:


Infection Communicable Diseases Bacterial Infections Skin Diseases, Infectious Skin Diseases	Vancomycin Aztreonam Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 26, 2016

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