Идёт набор NCT06219135

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

— Наблюдательное Sepsis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: no intervention - Contamination group, blood sample - Bacteraemia group, no intervention - Emergency group.
Кому может быть актуально: Состояния в реестре: Sepsis. Базовые параметры: от 1 Day · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Другое no intervention - Contamination group
there is no intervention for this group of patients
Биопрепарат blood sample - Bacteraemia group
for adult patients, in optional, blood sample will be taken. 27,5 ml of blood at H24-48 after inclusion and 5 ml of blood at day 30
Другое no intervention - Emergency group
there is no intervention for this group of patients

Первичные конечные точки

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 [Срок оценки: 24 Hours to 48 Hours after inclusion]
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 [Срок оценки: 24 Hours to 48 Hours after inclusion]

Критерии участия

Критерии включения

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