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NCT06300736 Clinical Trial

Design of a Predictive Score for Contamination of Pediatric Blood Cultures

Bacteremia Clinical Trial

— HEPIC  

Official title:
HEPIC Study : Design of a Predictive Score for Contamination of Pediatric Blood Cultures

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06300736
Other study ID # 2023PI247
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date October 1, 2024

Study information
Verified date March 2024
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The contamination rate for blood cultures is high in pediatrics, due to different sampling techniques and the difficulty of sampling small-weight children, thus favoring contamination of the devices at the time of sampling. It is also more difficult to distinguish contamination from true bacteremia in children at an early stage, notably due to the limited number of vials that can be taken at any one time. On a daily basis, clinicians are faced with the choice of whether or not to initiate probabilistic antibiotic therapy when faced with the result of a positive blood culture, particularly when identification is not yet available, but only direct examination. Contamination has major consequences for patient management. Studies in adults have shown that contamination increases hospital length of stay by 4 to 5 days, laboratory costs by +20% and recourse to intravenous antibiotic therapy by +39%. In children, studies came to the same conclusion, with greater prescription of antibiotics, particularly intravenous antibiotics, in patients with contaminated blood cultures than in patients with sterile blood cultures. It also showed that 26% of patients with contaminated blood cultures were initially hospitalized because of the positivity of this test. The aim of this research is to determine the factors associated with contamination, in order to create a predictive score that would help clinicians in their decision-making when receiving the blood culture result as "positive".

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Having a blood culture in children's hospital in Nancy - Under 18 years old - in emergency department, medical department, intensive care unit or surgical department Exclusion Criteria: - immunodepression - post mortem blood culture - blood culture in onco-haematology department

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU Nancy Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood culture diagnosis Contamination or bacteriemia 2 years
Secondary Score performance 2 years
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