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)

NCT04076345 | Terminated

• 2 other identifiers: RNI 2019 POIRIER2019-A00704-53
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn Sepsis; Fever

Keywords

presepsin; biomarker; newborns; infants under 3 months of age; fever; paediatric emergency

Outcome Measures

Primary Outcomes (1)

• Measure of Presepsin

  Presepsin rate measured in picograms / milliliters, using the PATHFAST analyzer.

  Day 0

Secondary Outcomes (4)

• Measure of C-reactive protein

  Day 0

• Measure of Procalcitonin

  Day 0

• Length of hospital stay

  through study completion, an average of one week

• Total costs

  through study completion, an average of one week

Study Arms (3)

Bacterial group

Newborns or infants less dans 3 months old with fever and positive bacterial sample.

Diagnostic Test: Prespesin assay on PATHFAST analyser

Viral group

Newborns or infants less dans 3 months old with fever and positive viral sample.

Diagnostic Test: Prespesin assay on PATHFAST analyser

Negatives Microbiological samples

Newborns or infants less dans 3 months old with fever and negatives microbiological samples.

Diagnostic Test: Prespesin assay on PATHFAST analyser

Interventions

Prespesin assay on PATHFAST analyser DIAGNOSTIC_TEST

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.

Bacterial group; Negatives Microbiological samples; Viral group

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Mitsubishi Chemical Europe: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (4)

• 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.

  PMID: 26720209 BACKGROUND

• 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.

  PMID: 21839732 BACKGROUND

• 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.

  PMID: 26743983 BACKGROUND

• 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.

  PMID: 24897403 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis; Fever

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Study Officials

• POIRIER Véronique

  CHU Estaing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 3, 2019
• Study Start: July 29, 2019
• Primary Completion: July 29, 2020
• Study Completion: July 29, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

FR (1)