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临床试验/NCT01174147
NCT01174147已完成不适用

Brazilian Network of Candidemia: a Laboratory-based Surveillance Study on Candida Bloodstream Infections in 10 Medical Centers

Merck Sharp & Dohme LLC0 个研究点目标入组 436 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
436
主要终点
Number of participants with Candidemia per 1000 hospital admissions

研究概览

简要总结

This study will evaluate the incidence rate of Candida blood stream infection (candidemia) among people hospitalized in participating medical centers in Brazil, and will assess the antifungal drug susceptibility patterns of Candida clinical isolates. No hypotheses will be tested in the study. Candida blood stream isolates collected from people hospitalized for any reason during the study period will be sent to a core mycology laboratory for antifungal drug susceptibility testing. All people who develop candidemia while hospitalized will be considered participants in the study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Hospitalized in a participating medical center
  • Developed candidemia blood stream infection (confirmed by isolation of Candida species from blood culture)

排除标准

  • 未提供

结局指标

主要结局

Number of participants with Candidemia per 1000 hospital admissions

时间窗: Approximately 1 year

A candidemia case was defined as the first isolation of any Candida species from blood within a 30-day period during hospitalization. The incidence of candidemia was calculated as (number of participants / \[number of total people hospitalized during the study period / 1000\])

Number of participants with Candidemia per 1000 patient-Days in hospital

时间窗: Approximately 1 year

A candidemia case was defined as the first isolation of any Candida species from blood within a 30-day period during hospitalization. The incidence of candidemia was calculated as (number of participants / \[number of total patient-days of hospitalization during the study period / 1000\]).

Percentage of Specific Candida Isolates Susceptible to Amphotericin B, Fluconazole, Voriconazole, Anidulafungin, and Caspofungin

时间窗: Approximately 1 year

Candida bloodstream isolates were tested for susceptibility to antifungal drugs using the Clinical and Laboratory Standards Institute (CLSI) microbroth dilution method with final readings recorded after 24 hours. The susceptibility cutoffs for antifungal drugs except amphotericin B were from the CLSI M27-S4 Reference Supplement (December 2012). The susceptibility cutoff for amphotericin B was obtained from the published literature.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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