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Sponsored by: |
Cerexa, Inc. |
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Information provided by: | Cerexa, Inc. |
ClinicalTrials.gov Identifier: | NCT00424190 |
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 |
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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 |
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 |
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A: Experimental
Ceftaroline for Injection
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Drug: Ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
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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.
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Additonal purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Ralph Corey, MD | Duke University |
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 |
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 |
Bacterial Infections Cephalosporins Aztreonam Anti-Infective Agents Skin Diseases Staphylococcal Skin Infections Anti-Bacterial Agents |
Cellulitis Skin Diseases, Infectious Abscess Skin Diseases, Bacterial Cefixime Vancomycin |
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Aztreonam Communicable Diseases |
Therapeutic Uses Vancomycin Infection Pharmacologic Actions |