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: vancomycin plus aztreonam Drug: Ceftaroline	Phase III

MedlinePlus related topics:

Antibiotics Bacterial Infections

ChemIDplus related topics:

Vancomycin Vancomycin hydrochloride Aztreonam Cefixime Ceftaroline fosamil

U.S. FDA Resources

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

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

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

microbiological success rate [ Designated as safety issue: No ]

Enrollment:	703
Study Start Date:	January 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Ceftaroline
B: Active Comparator	Drug: vancomycin plus aztreonam

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

Responsible Party:	Cerexa, Inc ( Sr. VP Clinical Development )
Study ID Numbers:	P903-06
First Received:	January 16, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00424190
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: Ethikkommision; 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

Study placed in the following topic categories:

Bacterial Infections

Aztreonam

Cephalosporins

Skin Diseases, Infectious

Cellulitis

Skin Diseases

Skin Diseases, Bacterial

Abscess

Cefixime

Vancomycin

Staphylococcal Skin Infections

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Communicable Diseases

Therapeutic Uses

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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