How to Reduce Unnecessary Blood Cultures: Construction and Validation of a Predictive Score for Blood Culture Positivity in Intensive Care (PROBIty)

February 29, 2024 updated by: University Hospital, Tours

Comment Diminuer Les hémocultures Inutiles : Construction et Validation d'un Score prédictif de positivité Des hémocultures en réanimation.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2411

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Brest, France
        • CHU Brest
      • Dijon, France
        • CHU Dijon
      • La Roche-sur-Yon, France
        • CHD La Roche sur Yon
      • Le Mans, France
        • CH Le Mans
      • Nantes, France
        • CHU Nantes
      • Orléans, France
        • CHR Orléans
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France
        • CHU Rennes
      • Strasbourg, France
        • CHIU Strasbourg
      • Tours, France, 37044
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

critical care patient with suspected infection.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
learning database group
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
Other: no intervention
no intervention
validation database group
The score will be validated on the remaining sample (800 patients), independent of the first sample. Both samples will be constituted by randomization.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the ROC curve of the predictive performance of the score for predicting bacteremia or fungemia.
Time Frame: day 1- day 28
day 1- day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the ROC curve of the diagnostic performance of body temperature to predict bacteremia or fungemia;
Time Frame: day 1- day 28
day 1- day 28
Area under the ROC curve of the diagnostic performance of the Shapiro score for predicting bacteremia or fungemia;
Time Frame: day 1- day 28
day 1- day 28
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;
Time Frame: day 1- day 28
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;
Time Frame: 48 hours
48 hours
Descriptive study of the contribution of blood cultures, whatever their results, to the prescription of anti-infectives.
Time Frame: day 1- day 28
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
Time Frame: 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.
less than 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Denis GAROT, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Actual)

September 27, 2023

Study Completion (Actual)

October 25, 2023

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR200089 (PROBIty)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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