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A Complicated Skin and Soft-tissue Infection Patient Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737269
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : March 4, 2013
Information provided by (Responsible Party):
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.

Condition or disease
Staphylococcal Skin Infections Diabetic Foot Infections Surgical Wound Infection Abscess Cellulitis

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.

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Study Type : Observational
Actual Enrollment : 1081 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737269

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
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Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
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Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC Identifier: NCT00737269    
Other Study ID Numbers: CR015043
CEFTOSSK4001 ( Other Identifier: Ortho-McNeil Janssen Scientific Affairs, LLC )
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013
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:
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Communicable Diseases
Wound Infection
Soft Tissue Infections
Surgical Wound Infection
Skin Diseases, Infectious
Staphylococcal Skin Infections
Diabetic Foot
Surgical Wound
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Pathologic Processes
Wounds and Injuries
Connective Tissue Diseases
Postoperative Complications
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections