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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections

Intervention: ceftaroline (Drug); vancomycin plus aztreonam (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Mark Wilcox, MD, Principal Investigator, Affiliation: Old Medical School

Summary

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

Clinical Details

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)

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 (TOC) (MITT Population)

The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the CE Populations.

Secondary outcome:

To Evaluate the Microbiological Success Rate at the TOC Visit

To Evaluate the Clinical Response at the End of Therapy (EOT) Visit

To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit

To Evaluate Clnical Relapse at the Late Follow Up (LFU) Visit

To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit

To Evaluate Safety

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

Eligibility

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.

Locations and Contacts

Investigational Site, Buenos Aires, Argentina

Investigational Site, Cordoba, Argentina

Investigational Site, Santa Fe, Argentina

Investigational Site, Braunau, Austria

Investigational Site, Graz 8036, Austria

Investigational Site, St. Polten 3100, Austria

Investigational Site, Sao Paula, Brazil

Investigational Site, Temuco, Chile

Investigational Site, Valdivia, Chile

Investigational Site, Cottbus 03048, Germany

Investigational Site, Dortmund 44145, Germany

Investigational Site, Homburg/Saar D-66421, Germany

Investigational Site, Mainz D-55101, Germany

Investigational Site, Wiesbaden 65191, Germany

Investigational Site, Riga LV-1001, Latvia

Investigational Site, Bielsko-Biala 43-316, Poland

Investigational Site, Krakow 31-501, Poland

Investigational Site, Kraków 31-820, Poland

Investigational Site, Lodz 91-425, Poland

Investigational Site, Lublin 20-954, Poland

Investigational Site, Poznań 61-848, Poland

Investigational Site, Warszawa 02-097, Poland

Investigational Site, Warszawa 03-401, Poland

Investigational Site, Wroclaw 50-326, Poland

Investigational Site, Moscow Region 143405, Russian Federation

Investigational Site, Moscow 111020, Russian Federation

Investigational Site, Moscow 119048, Russian Federation

Investigational Site, St. Petersburg 192242, Russian Federation

Investigational Site, St. Petersburg, Russian Federation

Investigational Site, Kharkov 61176, Ukraine

Investigational Site, Kyiv 03110, Ukraine

Investigational Site, Lviv 79044, Ukraine

Investigational Site, Zaporizhya 69000, Ukraine

Investigational Site, London N19 5LW, United Kingdom

Investigational Site, London SW10 9NH, United Kingdom

Investigational Site, Buena Park, California 90620, United States

Investigational Site, Hawaiian Gardens, California 90716, United States

Investigational Site, Los Angeles, California 90033, United States

Investigational Site, Pasadena, California 91105, United States

Investigational Site, San Diego, California 92114, United States

Investigational Site, San Jose, California 95124, United States

Investigational Site, Atlantis, Florida 33462, United States

Investigational Site, Columbus, Georgia 31904, United States

Investigational Site, Marietta, Georgia 30060, United States

Investigational Site, Springfield, Illinois 62701, United States

Investigational Site, Guadalajara, Jalisco 44280, Mexico

Investigational Site, Seattle Zapopan, Jalisco 45170, Mexico

Investigational Site, Baltimore, Maryland 21201, United States

Investigational Site, Minneapolis, Minnesota 55422, United States

Investigational Site, Butte, Montana 59701, United States

Investigational Site, Somers Point, New Jersey 08244, United States

Investigational Site, Toledo, Ohio 43608, United States

Investigational Site, Tacoma, Washington 98405, United States

Investigational Site, Milwaukee, Wisconsin 53215, United States

Additional Information

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

Page last updated: August 23, 2015

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