How to Reduce Unnecessary Blood Cultures: Construction and Validation of a Predictive Score for Blood Culture Positivity in Intensive Care
- Conditions
- Infection, FungalInfection, BacterialBacteremia
- Interventions
- Other: no intervention
- Registration Number
- NCT05686577
- Lead Sponsor
- University Hospital, Tours
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2411
- 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
- Patient already included in this study during a previous hospitalisation
- Opposition expressed for participation in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description validation database group no intervention The score will be validated on the remaining sample (800 patients), independent of the first sample. Both samples will be constituted by randomization. learning database group no intervention The results of blood cultures and the clinical elements of the patients in the first sample (1600 patients) will constitute the learning database. A supervised learning will be performed on these data in order to select a set of clinical elements allowing to define a predictive score of positive blood cultures
- Primary Outcome Measures
Name Time Method Area under the ROC curve of the predictive performance of the score for predicting bacteremia or fungemia. day 1- day 28
- Secondary Outcome Measures
Name Time Method Area under the ROC curve of the diagnostic performance of the Shapiro score for predicting bacteremia or fungemia; day 1- day 28 Area under the ROC curve of the diagnostic performance of body temperature to predict bacteremia or fungemia; day 1- day 28 Comparison of the diagnostic performance of the score in predicting bacteremia or fungemia observed during the first 48 hours of hospitalization to later bacteremias; 48 hours 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; day 1- day 28 Descriptive study of the contribution of blood cultures, whatever their results, to the prescription of anti-infectives. day 1- day 28 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 less than 1 month A tree decision model will compare three strategies for predicting positive blood cultures: the new predictive score, body temperature and Shapiro score. Within-trial data will be used to define the model parameters. The model will consider the costs related to the implementation of the strategies, blood cultures, and potential delays in patient management. This will result in the estimation of the two ICERs.
Trial Locations
- Locations (10)
CHU Brest
🇫🇷Brest, France
CHU Dijon
🇫🇷Dijon, France
CHD La Roche sur Yon
🇫🇷La Roche-sur-Yon, France
CH Le Mans
🇫🇷Le Mans, France
CHU Nantes
🇫🇷Nantes, France
CHU Poitiers
🇫🇷Poitiers, France
CHU Rennes
🇫🇷Rennes, France
CHR Orléans
🇫🇷Orléans, France
CHIU Strasbourg
🇫🇷Strasbourg, France
CHU de Tours
🇫🇷Tours, France