NCT02852902已完成不适用
Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
Spanish Network for Research in Infectious Diseases3 个研究点 分布在 1 个国家目标入组 820 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 试验地点
- 3
- 主要终点
- Cure rate
研究概览
简要总结
Main objective: to observationally assess the efficacy and safety of different antimicrobials in BSI due to ESBL or carbapenemase-producing Enterobacterales in SOT.
Secondary objectives:
- To evaluate the efficacy and safety of different antibiotics used for the treatment of infections caused by ESBL- and carbapenemase-producing Enterobacterales in the SOT population.
- To compare the efficacy of different antimicrobials between SOT and non-SOT patients (using matched controls from the "non-transplant" INCREMENT cohort).
- To create a microbiological collection of ESBL- and carbapenemase-producing Enterobacterales isolated from the SOT population.
- To provide data on specific MICs for each antimicrobial evaluated.
- To provide data on the prevalence of specific mechanisms of resistance and their clinical impact in the particular setting of SOT.
- To organise an international consortium capable of developing high quality prospective cohort studies and randomised clinical trials in the area of MDR and XDR Enterobacterales in SOT.
详细描述
METHODS
Study design: multicentre, international retrospective cohort study.
Sites: multiple expert investigators from different countries will be invited. Criteria for participation will include accessibility to a database with the required data or ability to retrospectively collect the data in a timely manner.
Procedure Centers will receive by email a personal key for access to an electronic Case Report File (CRF), on the official INCREMENT-SOT website at http://www.increment-sotproject.org/
The participant centres will be requested to include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Solid Organ Transplant patients, including multivisceral transplantation and transplant in HIV-infected recipients.
- •Episodes of clinically significant monomicrobial BSI due to cephalosporin-resistant Enterobacterales (CRE), specifically ESBL or carbapenemase-producing Enterobacterales, including community and nosocomial ones. Characterization of the resistance mechanisms should be based on the following criteria:
- •For cephalosporin resistance: a susceptibility phenotype based on a microdilution antibiogram.
- •For ESBL-producers: one phenotypic confirmation test according to current endpoints (i.e. CLSI, EUCAST) or PCR-based characterization.
- •For carbapenemase-producers: molecular detection of the carbapenemase gene or if the isolate showed an identical phenotype to previously characterized carbapenemase-producers detected at the same site.
- •Subsequent episodes in a patient caused by the same microorganism may be included if the interval between them is >3 months.
排除标准
- •Polymicrobial or non-clinically significant episodes. Episodes in which a potential contaminant (e.g., coagulase-negative staphylococci) is isolated only in one set of blood cultures and there is not a typical source of infection for that kind of organism (e.g. catheter-related) that can be included.
- •Unavailability of key data (such cases should be counted to analyse a potential selection bias).
- •Episodes occurring before January 2004.
结局指标
主要结局
Cure rate
时间窗: 14 days
Cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary
次要结局
- Clinical Improvement at 72 hours(72 hours)
- Clinical cure at 28 days(28 days)
- Mortality at 72 hours(72 hours)
- Mortality at 7 days(3 days)
- Mortality at 14 days(14 days)
- Mortality at 30 days(30 days)
研究者
研究点 (3)
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