Status:
COMPLETED
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
Lead Sponsor:
Forest Laboratories
Conditions:
Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
Detailed Description
Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
Eligibility Criteria
Inclusion
- 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
- Prior treatment of current complicated skin and skin structure infection (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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT00423657
Start Date
March 1 2007
End Date
December 1 2007
Last Update
March 14 2017
Active Locations (54)
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1
Investigational Site
Buena Park, California, United States, 90620
2
Investigational Site
Hawaiian Gardens, California, United States, 90716
3
Investigational Site
Los Angeles, California, United States, 90033
4
Investigational Site
Pasadena, California, United States, 91105