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)

Fever Clinical Trial

— presepsin  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04076345
• Other study ID #: RNI 2019 POIRIER
• Secondary ID: 2019-A00704-53
• Status: Terminated
• Start date: July 29, 2019
• Est. completion date: July 29, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Emergencies
• Fever
• Newborn Sepsis

Intervention

Diagnostic Test:
• Prespesin assay on PATHFAST analyser
Collection of parental non-opposition by the doctor taking care of the child. Addition of an additional 500µl tube to the usual blood sampling as part of the protocol for the management of children under 3 months of age with fever. This blood test contains CRP, PCT, NFS, Hemoculture. There is no additional venipuncture. This blood sample is taken by the nurse after parental non-opposition. Transfer of the sample to the laboratory. In the laboratory, centrifugation of the sample, taking the plasma alone which will be frozen. Delayed assay of presepsin, in series, after thawing of samples. Collection of data and analyzes by the principal investigator in collaboration with the statistician methodologist. The immunoassay of presepsin with PATHFAST is based on chemiluminescence.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Mitsubishi Chemical Europe

Country where clinical trial is conducted

France, 

References & Publications (4)

Chenevier-Gobeaux C, Bardet V, Poupet H, Poyart C, Borderie D, Claessens YE. Presepsin (sCD14-ST) secretion and kinetics by peripheral blood mononuclear cells and monocytic THP-1 cell line. Ann Biol Clin (Paris). 2016 Jan-Feb;74(1):93-7. doi: 10.1684/abc.2015.1112. — View Citation

Okamura Y, Yokoi H. Development of a point-of-care assay system for measurement of presepsin (sCD14-ST). Clin Chim Acta. 2011 Nov 20;412(23-24):2157-61. doi: 10.1016/j.cca.2011.07.024. Epub 2011 Aug 3. — View Citation

Pizzolato E, Ulla M, Galluzzo C, Lucchiari M, Manetta T, Lupia E, Mengozzi G, Battista S. Role of presepsin for the evaluation of sepsis in the emergency department. Clin Chem Lab Med. 2014 Oct;52(10):1395-400. doi: 10.1515/cclm-2014-0199. Review. — View Citation

Pugni L, Pietrasanta C, Milani S, Vener C, Ronchi A, Falbo M, Arghittu M, Mosca F. Presepsin (Soluble CD14 Subtype): Reference Ranges of a New Sepsis Marker in Term and Preterm Neonates. PLoS One. 2015 Dec 31;10(12):e0146020. doi: 10.1371/journal.pone.0146020. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Presepsin	Presepsin rate measured in picograms / milliliters, using the PATHFAST analyzer.	Day 0
Secondary	Measure of C-reactive protein	CRP level in milligrams / Liter	Day 0
Secondary	Measure of Procalcitonin	PCT rate in microgram/ Liter	Day 0
Secondary	Length of hospital stay	comparison between the presepsin rate and the duration of hospitalization to verify the prognostic power of presepsin (Day)	through study completion, an average of one week
Secondary	Total costs	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.	through study completion, an average of one week