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临床试验/NCT02604849
NCT02604849已完成不适用

Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin

Maimónides Biomedical Research Institute of Córdoba0 个研究点目标入组 44 人开始时间: 2012年7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
发起方
入组人数
44
主要终点
Mortality for any cause during a six-months period after oral therapy gut decontamination.

研究概览

简要总结

The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.

研究设计

研究类型
Observational
观察模型
Case Control
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 with intestinal colonization by Klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by Klebsiella pneumoniae:
  • Surgery in two weeks
  • Transplant in two weeks
  • Require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia)
  • Recurrent or severe infections
  • Institution admission
  • Fragile patients at high risk of readmission.

排除标准

  • The presence of an active infection for Klebsiella Pneumoniae.
  • Concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.

研究组 & 干预措施

Received therapy desconolizacion against Klebsiella pneumoniae

干预措施: Neomycin (Drug)

Received therapy desconolizacion against Klebsiella pneumoniae

干预措施: Streptomycin (Drug)

Received therapy desconolizacion against Klebsiella pneumoniae

干预措施: Gentamicins (Drug)

结局指标

主要结局

Mortality for any cause during a six-months period after oral therapy gut decontamination.

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Maimónides Biomedical Research Institute of Córdoba
申办方类型
Other
责任方
Sponsor

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