A Complicated Skin and Soft-tissue Infection Patient Registry

This study has been completed.
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
First received: August 14, 2008
Last updated: March 1, 2013
Last verified: March 2013
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
Staphylococcal Skin Infections
Diabetic Foot Infections
Surgical Wound Infection
Phase 4

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

Resource links provided by NLM:

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

Enrollment: 1081
Study Start Date: June 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with complicated skin and soft tissue infections (specifically, diabetic foot infections, surgical site infections, deep soft tissue abscess, cellulitis)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00737269     History of Changes
Other Study ID Numbers: CR015043  CEFTOSSK4001 
Study First Received: August 14, 2008
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
Complicated Skin and Soft-Tissue Infection
Skin Infection
Skin Infection Registry
cSSTI Registry

Additional relevant MeSH terms:
Communicable Diseases
Diabetic Foot
Skin Diseases, Infectious
Soft Tissue Infections
Staphylococcal Skin Infections
Surgical Wound Infection
Wound Infection
Bacterial Infections
Cardiovascular Diseases
Connective Tissue Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Ulcer
Gram-Positive Bacterial Infections
Leg Ulcer
Pathologic Processes
Postoperative Complications
Skin Diseases
Skin Diseases, Bacterial
Skin Ulcer
Staphylococcal Infections
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 26, 2016