A Complicated Skin and Soft-tissue Infection Patient Registry

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737269
• Other study ID #: CR015043
• Secondary ID: CEFTOSSK4001
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2008
• Last updated: March 1, 2013
• Start date: June 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2013
• Source: Ortho-McNeil Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1081
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Abscess
• Cellulitis
• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infections
• Infection
• Skin Diseases, Infectious
• Soft Tissue Infections
• Staphylococcal Skin Infections
• Surgical Wound Infection
• Wound Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ortho-McNeil Janssen Scientific Affairs, LLC