Status:
COMPLETED
A Complicated Skin and Soft-tissue Infection Patient Registry
Lead Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Staphylococcal Skin Infections
Diabetic Foot Infections
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receivin...
Detailed Description
A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who con...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of complicated skin and soft-tissue infection
- Patients who require IV antibiotic therapy as a primary treatment regimen
- Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information.
Exclusion
- Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis
- Patients for whom amputation or a complete resection of the infection site is a planned component of treatment
- Patients who are pregnant
- Patients simultaneously participating in any interventional clinical trial
- Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements
- Patients who are employees of the investigator or study hospital
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
1081 Patients enrolled
Trial Details
Trial ID
NCT00737269
Start Date
June 1 2008
End Date
January 1 2010
Last Update
March 4 2013
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