A Complicated Skin and Soft-tissue Infection Patient Registry

Completed

• Conditions: Staphylococcal Skin Infections; Diabetic Foot Infections; Surgical Wound Infection; Abscess; Cellulitis

• Registration Number: NCT00737269
• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC

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 receiving intravenous antibiotic therapy.

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 consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-18
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1081

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified