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临床试验/NCT01820455
NCT01820455已完成不适用

Methicillin-resistant Staphylococcus Aureus in a Trauma Population: Does Decolonization Prevent Infection?

University of Tennessee1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Number of patients decolonized following treatment

研究概览

简要总结

All trauma patients admitted to certain Intensive Care Units (ICU) will have Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA colonization status. Only those patients who are determined to be colonized with MRSA at admission will be included in the study. All patients must be age 18 and older, admitted directly to the ICU from either the Emergency Department or the operating room with trauma-related injuries, and must not have active or recent known history of MRSA infections. Once patients have been determined to be colonized with MRSA, they will be randomized to receive "decolonization" treatment or placebo. "Decolonization" treatment will include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail "routine" soap baths and Lubricating Jelly. Both groups will be kept on standard contact precautions throughout the course of the study. Repeat nasal swabs will be performed at the completion of the treatment regimen to determine the efficacy. Patients will be screened for invasive MRSA infections as dictated by their clinical course. The primary outcome measure will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay, mechanical ventilatory support requirements, colonization status at the end of treatment, and death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm over the course of 12-24 months.

详细描述

Partway through the enrollment period, it was determined that in the best interests of the patients, the protocol would be altered to eliminate the randomization process and treat all patients with the decolonization treatment regimen.

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
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

  • colonized with MRSA at admission
  • age of 18 years or older
  • admitted directly to the ICU from either the ED or the OR with trauma-related injuries

排除标准

  • active or recent known history of MRSA infection
  • previous institutionalization

研究组 & 干预措施

Chlorhexidine, Mupirocin

Active Comparator

Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days

干预措施: Chlorhexidine, Mupirocin (Drug)

Soap baths, Lubricating jelly

Placebo Comparator

Soap and water baths with lubricating jelly to each nare daily for 5 days

干预措施: Soap baths, Lubricating Jelly (Drug)

结局指标

主要结局

Number of patients decolonized following treatment

时间窗: Up to 24 months

Measurement of decolonization of MRSA as determined by polymerase chain reaction (PCR) from the nares of critically ill trauma population following treatment.

次要结局

  • Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized(up to 24 months)
  • Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources(up to 24 months)

研究者

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

Laura Brown

Research Coordinator

University of Tennessee

研究点 (1)

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