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临床试验/NCT01136200
NCT01136200已完成不适用

Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.

Henri Mondor University Hospital2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
264
试验地点
2
主要终点
Appropriateness of antimicrobial therapy

研究概览

简要总结

CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.

OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.

METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients:

  • Control group: antibiotic prescriptions will be initiated and managed by the attending physicians
  • Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.

STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical wards will participate by hospital. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Hospitalized in surgical or medical wards
  • Receiving antimicrobial therapy for active infection or prolonged surgical prophylaxis
  • Therapy prescribed by the attending ward physician

排除标准

  • Patients receiving antimicrobial therapy not prescribed by the attending ward physician

研究组 & 干预措施

Infectious disease specialist advice

Experimental

Patients receiving the intervention (infectious disease specialist advice)

干预措施: Infectious disease specialist advice (Other)

Control

No Intervention

Patients not receiving infectious disease specialist advice

结局指标

主要结局

Appropriateness of antimicrobial therapy

时间窗: Between days 7 and 10 after starting antimicrobial therapy

Appropriateness of antimicrobial therapy will be evaluated at the start, between days 3 and 5, and at the end of therapy (between days 7 and 10).

次要结局

  • Antibiotic exposure(14 days)
  • Clinical impact(Between days 7 and 10 after starting antimicrobial therapy)

研究者

发起方
Henri Mondor University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe LESPRIT

Dr Philippe LESPRIT

Henri Mondor University Hospital

研究点 (2)

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