跳至主要内容
临床试验/NCT00177957
NCT00177957已完成不适用

Gram Negative Bacteremia, Risk Factors for Failure of Therapy

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2005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
600
试验地点
1
主要终点
outcome of dead or alive post treatment

研究概览

简要总结

The aims of this study are to:

  • Determine the risk factors for multidrug resistance in bloodstream isolates of Gram negative bacilli
  • Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram negative bacilli
  • Determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria
  • Determine the survival of patients with Gram negative bacteremia
  • Determine if failure of prompt clearance of the blood of Gram negative bacteria is a predictor of mortality following this infection

详细描述

The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage within 14 days of onset of bacteremia, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of bacteremia, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history (please see attached clinical data collection worksheet dated 4/2005). We will also collect information retrospectively for one year and prospectively for one year. The bacteria in the patient's blood cultures will be subcultured (after the diagnosis has been obtained since the microbiology lab would otherwise destroy the culture) and provided to the honest broker who will deidentify the specimen and link it to the medical information collected (which will also be deidentified by the honest broker). The following evaluation will be performed on these samples. The minimal inhibitory concentration of the antibiotic used in treatment will be performed by the E-Test method (AB Biodisk, Solna, Sweden). Specific mechanisms of antimicrobial resistance will be studied with emphasis on the presence of beta-lactamases produced by the bacteria. This evaluation will be performed by analytical isoelectric focusing techniques as well as PCR and gene sequencing analysis to determine genes encoding beta-lactamases. Biologic samples will be under the control of the principal investigator of this research project. All samples provided to the investigators are deidentified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time with the research investigators have access to any patient identifiers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 at the aforementioned institutions that have Gram negative bacteremia will be included in the study.
  • Women with childbearing potential will also be included in this study. Since this is an observational study, no added risk is conferred to the woman or potential progeny. HIV serostatus will not be specifically investigated for participation in this study.

排除标准

  • 未提供

结局指标

主要结局

outcome of dead or alive post treatment

时间窗: December 2020

dead or alive

次要结局

未报告次要终点

研究者

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

Yohei Doi

Associate Professor

University of Pittsburgh

研究点 (1)

Loading locations...

相似试验