NCT00737269

A Complicated Skin and Soft-tissue Infection Patient Registry

A Prospective, Multi-center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,081 (actual)
• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Staphylococcal Skin Infections
• Diabetic Foot Infections
• Surgical Wound Infection
• Abscess
• Cellulitis

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-08-18
• Last updated: 2013-03-04