NCT06300736

Brief 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".

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

March 3, 2024

Last Update Submit

March 3, 2024

Conditions

Keywords

Blood culture contaminationPredictive score

Outcome Measures

Primary Outcomes (1)

  • Blood culture diagnosis

    Contamination or bacteriemia

    2 years

Secondary Outcomes (1)

  • Score performance

    2 years

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Immunocompetent children hospitalized in a tertiary children hospital with blood culture

You may qualify if:

  • 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

You may not qualify if:

  • immunodepression
  • post mortem blood culture
  • blood culture in onco-haematology department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nathan GIROUX, MD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 3, 2024

First Posted

March 8, 2024

Study Start

January 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations