Clinical trial NCT05686577: How to Reduce Unnecessary Blood Cultures: Construction and Validation of a Predictive Score for Blood Culture Positivity in Intensive Care
Official title: Comment Diminuer Les hémocultures Inutiles : Construction et Validation d'un Score prédictif de positivité Des hémocultures en réanimation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Bacterial
Infection, Fungal
Bacteremia
Keywords: intensive care unit
blood culture
prediction
score
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 2411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critical care patient with suspected infection.

Brief summary: Prospective observational cohort consisting of all adult patients admitted to participating critical care units (ICU and CCU) during the study period, with blood cultures collected as part of their care, and who did not express any objection to participating.

For each patient, data will be collected prospectively for each blood culture set collected.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 years or older
* Patient admitted to an ICU or ICU
* patient with a blood culture sample as part of care

Exclusion Criteria:

* Patient already included in this study during a previous hospitalisation
* Opposition expressed for participation in the study

Primary outcomes:
measure: Area under the ROC curve of the predictive performance of the score for predicting bacteremia or fungemia.
timeFrame: day 1- day 28
Secondary outcomes:
measure: Area under the ROC curve of the diagnostic performance of body temperature to predict bacteremia or fungemia;
timeFrame: day 1- day 28
measure: Area under the ROC curve of the diagnostic performance of the Shapiro score for predicting bacteremia or fungemia;
timeFrame: day 1- day 28
measure: Proportion of bacteremia or fungemia identified by blood cultures in patients on antibiotic therapy and broad-spectrum antibiotic therapy, and factors associated with these bacteremias or fungemias;
timeFrame: day 1- day 28
measure: Comparison of the diagnostic performance of the score in predicting bacteremia or fungemia observed during the first 48 hours of hospitalization to later bacteremias;
timeFrame: 48 hours
measure: Descriptive study of the contribution of blood cultures, whatever their results, to the prescription of anti-infectives.
timeFrame: day 1- day 28
measure: Efficiency of the new predictive score for blood culture positivity in Intensive Care, as compared with body temperature and Shapiro score, measured by two Incremental Cost-Effectiveness Ratios (ICER): ICER (incremental cost per additional well-detecte
timeFrame: less than 1 month
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: Dijon
country: France
facility: CHU Dijon
city: La Roche-sur-Yon
country: France
facility: CHD La Roche sur Yon
city: Le Mans
country: France
facility: CH Le Mans
city: Nantes
country: France
facility: CHU Nantes
city: Orléans
country: France
facility: CHR Orléans
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: CHIU Strasbourg
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: University Hospital, Tours
name: Denis GAROT
role: PRINCIPAL_INVESTIGATOR
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