跳至主要内容
临床试验/NCT03335592
NCT03335592终止不适用

Cost of Off-label Antibiotics in Osteoarticular Infections: Prospective Study Over 2 Years in a Reference Center for the Management of Complex Bone and Joint Infection

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,000
试验地点
1
主要终点
Estimation of the cost of the off-label antibiotics

研究概览

简要总结

Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting.

The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 having had off-label antibiotics between 2014 and 2015 to treat bone and/or joint infection, with or without implant and managed at the CRIOAc Lyon

排除标准

  • 未提供

结局指标

主要结局

Estimation of the cost of the off-label antibiotics

时间窗: 50 days

The molecule concerned are: daptomycin, ertapenem, linezolid, ceftaroline, tigecycline and / or colimycin. The characteristics of the patients, the type of bone and joint infection and the prescribing methods (dosage, duration) were collected throughout the care path (hospitalization in surgery and / or medicine at CRIOAc or in peripheral hospitals, in post-acute care structure and in the home). The duration of dispensation is about 50 days. Overall costs for off-label prescriptions were estimated taking account of variations in purchase price invoiced to the reference center.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eugénie MABRUT

Clinical Research Assistant

Hospices Civils de Lyon

研究点 (1)

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