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临床试验/NCT00737269
NCT00737269已完成不适用

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

Ortho-McNeil Janssen Scientific Affairs, LLC0 个研究点目标入组 1,081 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,081

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究者

申办方类型
Industry
责任方
Sponsor

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