Status:

TERMINATED

Interest of the Presepsin Assay as a Biomarker of Bacterial Infection, in the Management of Newborns and Infants Under 3 Months of Age Admitted for Fever in Pediatric Emergency Service (Presepsin)

Lead Sponsor:

University Hospital, Clermont-Ferrand

Collaborating Sponsors:

Mitsubishi Chemical Europe

Conditions:

Newborn Sepsis

Fever

Eligibility:

All Genders

1-3 years

Brief Summary

The purpose of this study is to validate presepsin as a biological marker for identifying bacterial fever among febrile syndromes of infants under three months of age. Clearly, our goal is to determin...

Detailed Description

An exploratory proof of concept that evaluates an innovative and minimally invasive diagnostic technique, with brief, monocentric longitudinal follow-up, this study aims to validate presepsin as a bio...

Eligibility Criteria

Inclusion

  • Children under 3 months old with fever, a rectal temperature greater than or equal to 38 ° C, presenting at the pediatric emergency of the Estaing Hospital or directly in pediatric intensive care unit of the Estaing Hospital.
  • Coverage by a social security scheme

Exclusion

  • Failure to perform a blood test
  • Children who received antibiotics before admission.
  • Refusal of participation by the legal representatives of the child
  • Concomitant participation of the child in a therapeutic trial or other clinical study that may influence the results of this research

Key Trial Info

Start Date :

July 29 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 29 2020

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT04076345

Start Date

July 29 2019

End Date

July 29 2020

Last Update

October 8 2020

Active Locations (1)

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CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, France, 63003