Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.
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
- 否
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
Patients receiving the intervention (infectious disease specialist advice)
干预措施: Infectious disease specialist advice (Other)
Control
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
Philippe LESPRIT
Dr Philippe LESPRIT
Henri Mondor University Hospital
