A Complicated Skin and Soft-tissue Infection Patient Registry

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.

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Key information

Conditions

Staphylococcal Skin Infections Abscess Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Diabetic Foot Infections Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Soft Tissue Infections Staphylococcal Infections Suppuration Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Ortho-McNeil Janssen Scientific Affairs, LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Aug 18, 2008
Registry last updated: Mar 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed