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

Bacterial Infections Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroloine Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423657
• Other study ID #: P903-07
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2007
• Last updated: November 23, 2010
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: November 2010
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeAustria: EthikkommissionAustria: Federal Ministry for Health and WomenGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ministry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Human Research Bioethics CommitteeBrazil: National Committee of Ethics in ResearchBrazil: Ministry of HealthBrazil: National Health Surveillance AgencyChile: Comisión Nacional de Investigación Científica y TecnológicaChile: Instituto de Salud Pública de ChileMexico: Ethics CommitteeMexico: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksPeru: Ethics CommitteePeru: General Directorate of Pharmaceuticals, Devices, and DrugsPeru: Ministry of HealthLatvia: State Agency of MedicinesRussia: Ministry of Health of the Russian FederationUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

Additonal purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection

Intervention

Drug:
• ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
• 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.
• Placebo
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Locations

Country	Name	City	State
Argentina	Investigational Site	Buenos Aires
Argentina	Investigational Site	Cordoba
Argentina	Investigational Site	Santa Fe
Austria	Investigational Site	Braunau
Austria	Investigational Site	Graz
Austria	Investigational Site	St. Polten
Brazil	Investigational Site	Sao Paula
Chile	Investigational Site	Temuco
Chile	Investigational Site	Valdivia
Germany	Investigational Site	Cottbus
Germany	Investigational Site	Dortmund
Germany	Investigational Site	Homburg/Saar
Germany	Investigational Site	Mainz
Germany	Investigational Site	Wiesbaden
Latvia	Investigational Site	Riga
Mexico	Investigational Site	Guadalajara	Jalisco
Mexico	Investigational Site	Seattle Zapopan	Jalisco
Poland	Investigational Site	Bielsko-Biala
Poland	Investigational Site	Krakow
Poland	Investigational Site	Kraków
Poland	Investigational Site	Lodz
Poland	Investigational Site	Lublin
Poland	Investigational Site	Poznan
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Wroclaw
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow Region
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Ukraine	Investigational Site	Kharkov
Ukraine	Investigational Site	Kyiv
Ukraine	Investigational Site	Lviv
Ukraine	Investigational Site	Zaporizhya
United Kingdom	Investigational Site	London
United Kingdom	Investigational Site	London
United States	Investigational Site	Atlantis	Florida
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Buena Park	California
United States	Investigational Site	Butte	Montana
United States	Investigational Site	Columbus	Georgia
United States	Investigational Site	Hawaiian Gardens	California
United States	Investigational Site	Los Angeles	California
United States	Investigational Site	Marietta	Georgia
United States	Investigational Site	Milwaukee	Wisconsin
United States	Investigational Site	Minneapolis	Minnesota
United States	Investigational Site	Pasadena	California
United States	Investigational Site	San Diego	California
United States	Investigational Site	San Jose	California
United States	Investigational Site	Somers Point	New Jersey
United States	Investigational Site	Springfield	Illinois
United States	Investigational Site	Tacoma	Washington
United States	Investigational Site	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Chile,  Germany,  Latvia,  Mexico,  Poland,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure Rate at Test of Cure (TOC) (MITT Population)	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	8-15 days after last dose of study drug administration	No
Primary	The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the CE Populations.		8-15 days after last dose of study drug	No
Secondary	To Evaluate the Microbiological Success Rate at the TOC Visit		8-15 days after the last dose of study drug	No
Secondary	To Evaluate the Clinical Response at the End of Therapy (EOT) Visit		last day of study drug administration	No
Secondary	To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit		8-15 days after last dose of study drug	No
Secondary	To Evaluate Clnical Relapse at the Late Follow Up (LFU) Visit		21 to 35 days after the last dose of study drug	No
Secondary	To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit		21-35 days after last dose of study drug	Yes
Secondary	To Evaluate Safety		first study drug dose through TOC	Yes