A Complicated Skin and Soft-Tissue Infection Patient Registry

This study is currently recruiting participants.

Verified by Ortho-McNeil Janssen Scientific Affairs, LLC, December 2008

Sponsored by:	Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:	Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00737269

Purpose

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.

Condition	Phase
Surgical Wound Infection Abscess Cellulitis Diabetic Foot Infections Staphylococcal Skin Infections	Phase IV

MedlinePlus related topics: Antibiotics Cellulitis Diabetic Foot Foot Health

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Prospective, Multi-Center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy

Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Estimated Enrollment:	1200
Study Start Date:	May 2008

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.

N/A

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737269

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

info1@veritasmedicine.com

Show 36 Study Locations

Sponsors and Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

Study Director:

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Ortho-McNeil Janssen Scientific Affairs, LLC

More Information

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR015043
Study First Received:	August 14, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00737269
Health Authority:	United States: Institutional Review Board

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Skin Infection Registry
Complicated Skin and Soft-Tissue Infection
Skin Infection
cSSTI Registry

Study placed in the following topic categories:

Bacterial Infections
Disorders of Environmental Origin
Surgical Wound Infection
Diabetic Angiopathies
Cellulitis
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial
Connective Tissue Diseases
Suppuration
Diabetes Complications
Wound Infection
Foot Ulcer
Soft Tissue Infections
Diabetic Neuropathies
Skin Diseases

Ulcer
Diabetes Mellitus
Wounds and Injuries
Vascular Diseases
Endocrine System Diseases
Staphylococcal Skin Infections
Inflammation
Staphylococcal Infections
Skin Diseases, Infectious
Postoperative Complications
Abscess
Endocrinopathy
Skin Ulcer
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Communicable Diseases
Pathologic Processes
Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009