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: vancomycin plus aztreonam Drug: Ceftaroline	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bacterial Infections Skin Conditions

Drug Information available for: Aztreonam Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

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 Ceftaroline for Injection	Drug: Ceftaroline 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
B: Active Comparator	Drug: vancomycin plus 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.

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.

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

Responsible Party:	Cerexa, Inc ( Senior Vice President, Clinical Development )
Study ID Numbers:	P903-06
Study First Received:	January 16, 2007
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00424190 History of Changes
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
Anti-Infective Agents
Anti-Bacterial Agents
Aztreonam
Communicable Diseases
Skin Diseases, Infectious

Skin Diseases
Therapeutic Uses
Vancomycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009