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临床试验/NCT00156377
NCT00156377已完成4 期

Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus

University Hospital Muenster2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2002年11月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
1,200
试验地点
2
主要终点
Staphylococcus aureus infection any time after 5 days of mupirocin ointment

研究概览

简要总结

In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent Staphylococcus aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections.

详细描述

In a past study, we showed that there is a strong correlation between strains colonizing the anterior nares, strains isolated from the presumed foci of infection, and strains isolated from blood in patients with Staphylococcus aureus bacteremia. These results suggested that a substantial proportion of cases of systemic S. aureus infections appear to be of endogenous origin and that eradication of nasal colonization should be the chief strategy for reducing the incidence of hospital-acquired S. aureus infections.

In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent S. aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections. All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster were regularly screened for nasal carriage, i.e. at admission and, subsequently, on a weekly basis. S. aureus carrying patients were prospectively randomized, to be either treated with mupirocin for 5 days, or left untreated. Patients infected with S. aureus at admission and patients detected to be MRSA carrier were excluded from randomization.

Patients were regularly seen during the course of their hospital stay and predisposing/conditional risk factors were systematically documented. In both groups (untreated patients and patients with mupirocin prophylaxis), all nosocomial infections were documented according to CDC guidelines. If infected, specimens were taken for microbiological diagnosis. All S. aureus isolates (from the anterior nares as well as from the focus of infection) were collected and were genotyped.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster (following information on the study and agreement of the patient).

排除标准

  • Patients infected with S. aureus at admission
  • S. aureus infection within 48 hours following admission
  • Patients detected to be carrier of Methicillin-resistant S. aureus
  • Hospital stay shorter than 72 hours
  • Patients with anatomic abnormalities in the anterior nares
  • Allergy or hypersensitivity to mupirocin or other substances of the nasal ointment
  • Persons younger than 18 years
  • Known pregnancy
  • Persons with psychiatric diseases
  • Persons with limited contractual capability and judiciousness

结局指标

主要结局

Staphylococcus aureus infection any time after 5 days of mupirocin ointment

次要结局

  • Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay

研究者

发起方
University Hospital Muenster
申办方类型
Other

研究点 (2)

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