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临床试验/NCT00894036
NCT00894036Unknown不适用

Epidemiology of Extended-spectrum ß-lactamase (ESBL)-Producing Enteric Gram-negative Bacilli in Swiss Children

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Burden of ESBL-colonization and disease of hospitalized Swiss children

研究概览

简要总结

Objectives:

The aim of the study is to determine the molecular epidemiology and genetic variability of ESBL-producing enterobacteriaceae (E-ESBL) among children in Switzerland and to estimate the associated clinical burden of disease.

The investigators' hypotheses are:

  1. The genetic variability (and especially the distribution of strains harbouring the CTX-M genes) among children is similar to that observed in adults;
  2. The overall burden of disease is still low in Switzerland compared to neighbouring countries. However, treatment of severe E-ESBL infections is challenging;
  3. The recommended oral treatment procedure with 3rd generation cephalosporins for febrile urinary tract infection may contribute to increased prevalence of E-ESBL in the long term.

The study is scheduled to start July 1st, 2008, and end June 30th, 2010.

详细描述

Background & Rationale:

Increasing resistance to antibiotics is a growing problem in public health and is associated with treatment failures, increased health care costs, and prolonged hospital stays. Over the past years, one mechanism of resistance has been of particular concern: ESBL, which is produced mainly by Escherichia coli and Klebsiella species but also found in other gram negative bacteria. ESBLs are plasmid-encoded ß-lactamases conferring resistance to penicillins, cephalosporins and aztreonam.

ESBL-producing enterobacteria are usually susceptible to carbapenems, such as ertapenem, imipenem or meropenem. Thus, treatment with carbapenems remains safe if the presence of ESBL is recognized. However, the confirmation of ESBL is not always a routine procedure in all laboratories. Furthermore, ESBL strains with high resistance to ertapenem and decreased activity to imipenem and meropenem have already been described. The mechanism among these strains however, appears to be a combination of the expression of ESBL and impermeability or increased efflux for carbapenems. Infection with ESBL-producing E. coli or K. pneumoniae is potentially hazardous for patients. Mortality is significantly higher following a bloodstream infection caused by ESBL producing E. coli compared to non-ESBL producing strains.

ESBLs are encoded on plasmids: classically, these plasmid mediated enzymes have been of the TEM and SHV type. However, in recent years CTX-M-type ESBLs have been increasingly identified worldwide throughout the world. CTX-M enzymes predominantly hydrolyze cefotaxime, but are weakly active against ceftazidime. However, some ESBLs of the CTX-M family also display increased hydrolytic activities against ceftazidime, as is the case for CTXM-15 and CTX-M-32.

The prevalence of ESBL producing enterobacteria and particularly E. coli has significantly increased in recent years. This increase is primarily due to the spread of ESBL of the CTX-M-type. Genes encoding CTX-M enzymes are associated with mobile genetic elements allowing these enzymes to spread throughout the community. Well established primer sets are used in polymerase chain reaction (PCR) tests for the detection of the blaTEM, blaSHV, and blaCTX-M genes, and are used to differentiate ESBL strains.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
— 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children who are found being colonized or infected by an ESBL-producing pathogen

排除标准

  • children without ESBL-producing pathogens

结局指标

主要结局

Burden of ESBL-colonization and disease of hospitalized Swiss children

时间窗: 2 years

次要结局

  • Genetic variability (and especially the distribution of strains harbouring the CTX-M genes) among Swiss children(2 years)

研究者

申办方类型
Other

研究点 (1)

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