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

Bacterial Infections Clinical Trial

— cSSSI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424190
• Other study ID #: P903-06
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2007
• Last updated: November 23, 2010
• Start date: February 2007
• Est. completion date: November 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 BoardItaly: National Bioethics CommitteeItaly: Ministry of HealthGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ministry of HealthSwitzerland: EthikkommissionSwitzerland: SwissmedicArgentina: 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 HealthRomania: National Medicines AgencyRomania: State Institute for Drug ControlRussia: Ethics CommitteeRussia: 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:

Additional purpose of the 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: 698
• Est. completion date: November 2007
• Est. primary completion date: November 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:
• 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.
• Ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

Locations

Country	Name	City	State
Argentina	Investigational Site	Buenos Aires
Argentina	Investigational Site	Buenos Aires
Argentina	Invetigational Site	Buenos Aires
Argentina	Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	Investigational Site	Cordoba
Argentina	Invetigational Site	Cordoba
Argentina	Investigational Site	Entre Rios
Argentina	Investigational Site	Santa Fe
Brazil	Investigational Site	Curiuba-Parans
Brazil	Investigational Site	Sao Paulo
Chile	Investigational Site	Santiago
Chile	Investigational Site	Vina del Mar
Germany	Investigational Site	Berlin
Germany	Investigational Site	Bochum
Germany	Investigational Site	Hanau
Germany	Investigational Site	Plauen
Germany	Investigational Site	Quedlinburg
Mexico	Investigational Site	Chihuahua
Peru	Invetigational Site	Lima
Poland	Investigational Site	Bytom
Poland	Investigational Site	Krakow
Poland	Investigational Site	Lublin
Poland	Investigational Site	Sosnowiec
Poland	Investigational Site	Todz
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Timisoara
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Smolensk
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Ukraine	Investigational Site	Dnipropetrovsk
Ukraine	Investigational Site	Ivano-Frankivsk
Ukraine	Investigational Site	Lviv
United States	Investigational Site	Columbus	Ohio
United States	Investigational Site	Dothan	Alabama
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational Site	Landsdale	Pennsylvania
United States	Investigational Site	Long Beach	California
United States	Investigational Site	Los Angeles	California
United States	Investigational Site	Naperville	Illinois
United States	Investigational Site	Sacramento	California
United States	Investigational Site	Sacramento	California
United States	Investigational Site	San Diego	California
United States	Investigational Site	San Francisco	California
United States	Investigational Site	Savannah	Georgia
United States	Investigational Site	Shreveport	Louisiana
United States	Investigational Site	Tacoma	Washington
United States	Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  Germany,  Mexico,  Peru,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure Rate at Test of Cure (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 the end of treatment	No
Primary	Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population		8-15 days after last dose of study drug	No
Secondary	Microbiological Success Rate at the TOC Visit		8-15 days after last dose of study drug	No
Secondary	Clinical Response at the End of Therapy (EOT) Visit		Last day of study drug administration	No
Secondary	Clinical and Microbiological Response by Pathogen at the TOC Visit		8-15 days after last dose of study drug	No
Secondary	Clinical Relapse at the Late Follow Up (LFU) Visit		21 to 35 days after the last dose of study drug	No
Secondary	Microbiological Reinfection or Recurrence at the LFU Visit		21 to 35 days after the last dose of study drug	No
Secondary	Assess Safety	Comparisons of the number of participants with Adverse Events	First dose of study drug through TOC visit	No