A Complicated Skin and Soft-tissue Infection Patient Registry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00737269

Enrollment

1081

Registered

2008-08-18

Start date

2008-06-30

Completion date

2010-01-31

Last updated

2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess, Cellulitis, Diabetic Foot Infections, Staphylococcal Skin Infections, Surgical Wound Infection

Keywords

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

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.

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results