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)

Terminated

• Conditions: Fever; Newborn Sepsis

• Registration Number: NCT04076345
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 determine if this marker can help us distinguish a viral infection from a bacterial infection. Indeed, presepsin would be specific for bacterial infection, and rise earlier in the blood during infection than biological markers currently used. Such validation could improve the precocity of the therapeutic management by a better targeted antibiotic therapy, and the limitation of invasive complementary examinations (lumbar puncture), in infants for whom the fear of a bacterial infection leads to examinations and systematic treatments.

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 biomarker for identifying bacterial fever among febrile syndromes of infants under three months of age. Presepsin is thought to be specific for sepsis, and would rise earlier in the blood during sepsis than biomarkers currently used. Such validation could improve the precocity of the therapeutic management by a better targeted antibiotic therapy, and the limitation of invasive complementary examinations (lumbar puncture), in infants for whom the fear of a bacterial infection leads to examinations and systematic treatments.

To do this, we will study the discriminative power (bacterial or viral, verified, a posteriori, by the results of microbiological examinations such as blood cultures, cytobacteriology of urine, lumbar puncture, virological or bacteriological samples of stool and nasopharynx) and prognosis (comparison of initial signs of clinical severity and presepsin levels, length of hospitalization and hospitalization unit) of presepsin by comparing its blood levels to the usual biological markers (CRP, PCT, leukocytes, neutrophils, lymphocytes) in children less than 3 months old with fever. It will also be compared, a posteriori, the rate of presepsin between the group of children treated with antibiotics and the group of untreated children to verify that the rate of presepsin is predictive of the initiation of antibiotic treatment.

If in this study the superiority of presepsin is confirmed, it will also be evaluated, by a medico-economic study, the effect of a decision of care based on the interpretation of the blood presepsin level on downstream health costs and on the speed of care of children under 3 months with fever presenting to the emergency department by the commissioning of a delocalized analyzer. This device is, for the moment, available only in the laboratory.

The study plans to include 160 children under 3 months admitted to pediatric emergencies or pediatric resuscitation at Estaing Hospital in Clermont-Ferrand.

Participation in the study will not require additional venipuncture given the very small amount of blood sufficient for the presepsin assay. The diagnosis of the child will not be made according to the presepsin test, but according to the standard criteria, and its management will not be modified by his participation in the study. Thus, the study presents neither benefit nor risk for the participants.

Study Timeline

• Study Start: 2019-07-29
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Primary Completion: 2020-07-29
• Study Completion: 2020-07-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of Presepsin	Day 0	Presepsin rate measured in picograms / milliliters, using the PATHFAST analyzer.

Secondary Outcome Measures

Name	Time	Method
Measure of Procalcitonin	Day 0	PCT rate in microgram/ Liter
Total costs	through study completion, an average of one week	Total costs represents cost of presepsin assay, cost of CRP and PCT assay, average cost per day of a hospital stay of a febrile child less than 3 months depending on the unit, laboratory personal cost (in euros). This allows the evaluation, by a medico-economic study, of the effect of a decision of care based on the interpretation of the blood pressepsin level on the downstream health costs and on the speed of taking care of patients children under 3 months with fever presenting to the emergency department by setting up a delocalized analyzer.
Length of hospital stay	through study completion, an average of one week	comparison between the presepsin rate and the duration of hospitalization to verify the prognostic power of presepsin (Day)
Measure of C-reactive protein	Day 0	CRP level in milligrams / Liter

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France