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OpenTrials
Completed

NCT Number: NCT05686577

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

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.

Completed

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Key information

Conditions

Infection, Bacterial Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infection, Fungal Infections Inflammation Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brest, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Area under the ROC curve of the predictive performance of the score for predicting bacteremia or fungemia.

    Time frame: day 1- day 28

Secondary outcomes

  1. Area under the ROC curve of the diagnostic performance of body temperature to predict bacteremia or fungemia;

    Time frame: day 1- day 28

  2. Area under the ROC curve of the diagnostic performance of the Shapiro score for predicting bacteremia or fungemia;

    Time frame: day 1- day 28

  3. 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

  4. 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

  5. Descriptive study of the contribution of blood cultures, whatever their results, to the prescription of anti-infectives.

    Time frame: day 1- day 28

  6. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: PROBIty

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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