A Complicated Skin and Soft-tissue Infection Patient Registry
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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 |
|---|---|
|
Staphylococcal Skin Infections Diabetic Foot Infections Surgical Wound Infection Abscess Cellulitis |
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 |
| 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) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 More Information
No publications provided
| 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:
|
Abscess Cellulitis Skin Diseases, Infectious Staphylococcal Skin Infections Surgical Wound Infection Wound Infection Soft Tissue Infections Diabetic Foot Focal Infection Suppuration Infection Inflammation Pathologic Processes Connective Tissue Diseases Skin Diseases |
Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Skin Diseases, Bacterial Postoperative Complications Wounds and Injuries Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Foot Ulcer Leg Ulcer Skin Ulcer Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013