跳至主要内容
临床试验/NCT06219135
NCT06219135招募中不适用

Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis

Hospices Civils de Lyon13 个研究点 分布在 1 个国家目标入组 1,372 人开始时间: 2024年3月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
1,372
试验地点
13
主要终点
The IDBIORIV method will be compared with the current routine methods present in the Hospices Civils de Lyon. The sensitivity and specificity of the IDBIORIV method will be evaluated using AST results. Reference technique = Vitek 2® bioMérieux

研究概览

简要总结

Sepsis is a disruption of homeostasis in the human body in response to bloodstream infection and is associated with a high risk of mortality.

Worldwide, sepsis is affecting approximately 30 million people and resulting in six million deaths.

Blood culture is a specific blood sample used to identifying microbial agent (bacterium or yeast) and determine the sensitivity of these microorganisms to antibiotics and antifungals.

Any delay in identifying the microorganism and/or determining the AST (antibiotic susceptibility testing) has a direct impact on the administration of appropriate antibiotic treatment and, consequently, on mortality of the patient. The faster the diagnosis, the faster the antibiotic treatment will be adapted, the higher the survival rate/probability of patients, and the lower the ecological impact.

In routine, clinical microbiology laboratories currently use 2 automatized techniques: MALDI-TOF MS® for microorganisms identification and VITEK2® method for AST determination.

Based on a proteomic approach, the IDBIORIV method is a rapid method (90 minutes) in comparison of current methods (24/48 hours) able to identifying a large panel of 113 pathogens and determine the antibiotic resistance profile of 49 species for 4 classes of antibiotics (Beta-lactams, Aminosides, Glycopeptides, Colistin).

The main objective of this study is to evaluate the performance of the IDBIORIV method in pathogen identification and antibiotic susceptibility testing in comparison with current methods of analysis of positive blood cultures used at the microbiology laboratory of the Hospices Civils de Lyon, in a real clinical situation, over a 2-year period.

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
1 Day 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult or child patient
  • •Hospitalized in one of the departments registered with Hospices Civils de Lyon
  • •Showing signs of infection
  • •Confirmed by a 1st positive blood culture
  • •Patient or close relative (trustworthy person or family member) or holder of parental authority who has given his or her non-objection after receiving the information note

排除标准

  • •Patients under court protection
  • •Patients under guardianship or curatorship

研究组 & 干预措施

Contamination

Patients with a positive blood culture due to contamination microorganism

干预措施: no intervention - Contamination group (Other)

Bacteraemia

This group includes all adults and children with a positive blood culture due to pathogen microorganism

干预措施: blood sample - Bacteraemia group (Biological)

Emergency

Emergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism

干预措施: no intervention - Emergency group (Other)

结局指标

主要结局

The IDBIORIV method will be compared with the current routine methods present in the Hospices Civils de Lyon. The sensitivity and specificity of the IDBIORIV method will be evaluated using AST results. Reference technique = Vitek 2® bioMérieux

时间窗: 24 Hours to 48 Hours after inclusion

The performance of the IDBIORIV method for in vitro diagnosis of antibiotic-resistant/susceptible status will be evaluated for each "species-antibiotic" pair and "species-antibiotic group" of interest. Sensitivity will be calculated as the proportion of pairs diagnosed as resistant using the IDBIORIV method among pairs diagnosed as resistant using AST. Specificity will be calculated as the proportion of pairs diagnosed as sensitive with the IDBIORIV method among pairs diagnosed as sensitive with AST.

The IDBIORIV method will be compared with the current routine methods present in the Hospices Civils de Lyon. The sensitivity and specificity of the IDBIORIV method will be evaluated using the Identification (ID) results of a positive blood culture for a

时间窗: 24 Hours to 48 Hours after inclusion

Reference technique used = Vitek MS ® (MALDI-ToF) bioMérieux.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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