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

Condition(s) targeted: Bacterial Infections

Intervention: IV Vancomycin plus IV Aztreonam (Drug); Ceftaroline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Ralph Corey, MD, Principal Investigator, Affiliation: Duke University

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

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

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

Primary outcome:

Clinical Cure Rate at Test of Cure (MITT Population)

Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population

Secondary outcome:

Microbiological Success Rate at the TOC Visit

Clinical Response at the End of Therapy (EOT) Visit

Clinical and Microbiological Response by Pathogen at the TOC Visit

Clinical Relapse at the Late Follow Up (LFU) Visit

Microbiological Reinfection or Recurrence at the LFU Visit

Assess Safety

Detailed description: Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Investigational Site, Buenos Aires, Argentina

Investigational Site, Buenos Aires 164, Argentina

Invetigational Site, Buenos Aires, Argentina

Investigational Site, Ciudad Autónoma de Buenos Aires 1240 C1180AAX, Argentina

Investigational Site, Cordoba, Argentina

Invetigational Site, Cordoba, Argentina

Investigational Site, Entre Rios, Argentina

Investigational Site, Santa Fe, Argentina

Investigational Site, Curiuba-Parans 1089, Brazil

Investigational Site, Sao Paulo 04039-020, Brazil

Investigational Site, Santiago, Chile

Investigational Site, Vina del Mar, Chile

Investigational Site, Berlin D-10249, Germany

Investigational Site, Bochum 44791, Germany

Investigational Site, Hanau, Germany

Investigational Site, Plauen 08529, Germany

Investigational Site, Quedlinburg 06484, Germany

Investigational Site, Chihuahua 31238, Mexico

Invetigational Site, Lima 29, Peru

Investigational Site, Bytom 41-902, Poland

Investigational Site, Krakow 31-913, Poland

Investigational Site, Lublin 20-081, Poland

Investigational Site, Sosnowiec 41-200, Poland

Investigational Site, Todz 91-425, Poland

Investigational Site, Bucharest 010816, Romania

Investigational Site, Bucharest 041915, Romania

Investigational Site, Timisoara 300736, Romania

Investigational Site, Moscow 129327, Russian Federation

Investigational Site, Moscow 111539, Russian Federation

Investigational Site, Moscow 105229, Russian Federation

Investigational Site, Smolensk 214019, Russian Federation

Investigational Site, St. Petersburg 192242, Russian Federation

Investigational Site, St. Petersburg 194354, Russian Federation

Investigational Site, St. Petersburg 196247, Russian Federation

Investigational Site, Dnipropetrovsk 49600, Ukraine

Investigational Site, Ivano-Frankivsk 76008, Ukraine

Investigational Site, Lviv 79659, Ukraine

Investigational Site, Dothan, Alabama 36301, United States

Investigational Site, Long Beach, California 90813, United States

Investigational Site, Los Angeles, California 90015, United States

Investigational Site, Sacramento, California 95819, United States

Investigational Site, Sacramento, California 95817, United States

Investigational Site, San Diego, California 92114, United States

Investigational Site, San Francisco, California 94110, United States

Investigational Site, Torrance, California 90509, United States

Investigational Site, Savannah, Georgia 31405, United States

Investigational Site, Naperville, Illinois 60540, United States

Investigational Site, Indianapolis, Indiana 46280, United States

Investigational Site, Shreveport, Louisiana 71103, United States

Investigational Site, Columbus, Ohio 43215, United States

Investigational Site, Landsdale, Pennsylvania 19446, United States

Investigational Site, Tacoma, Washington 98405, United States

Starting date: February 2007
Last updated: November 23, 2010