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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) (presepsin)

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ClinicalTrials.gov Identifier: NCT04076345
Recruitment Status : Terminated (investigator not available)
First Posted : September 3, 2019
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Mitsubishi Chemical Europe
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Newborn Sepsis Fever Diagnostic Test: Prespesin assay on PATHFAST analyser

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.

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 29, 2019
Actual Primary Completion Date : July 29, 2020
Actual Study Completion Date : July 29, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bacterial group
Newborns or infants less dans 3 months old with fever and positive bacterial sample.
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.


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


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





Primary Outcome Measures :
  1. Measure of Presepsin [ Time Frame: Day 0 ]
    Presepsin rate measured in picograms / milliliters, using the PATHFAST analyzer.


Secondary Outcome Measures :
  1. Measure of C-reactive protein [ Time Frame: Day 0 ]
    CRP level in milligrams / Liter

  2. Measure of Procalcitonin [ Time Frame: Day 0 ]
    PCT rate in microgram/ Liter

  3. Length of hospital stay [ Time Frame: 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)

  4. Total costs [ Time Frame: 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.



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076345


Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Mitsubishi Chemical Europe
Investigators
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Principal Investigator: POIRIER Véronique CHU Estaing
Publications:
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04076345    
Other Study ID Numbers: RNI 2019 POIRIER
2019-A00704-53 ( Other Identifier: ANSM )
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
presepsin
biomarker
newborns
infants under 3 months of age
fever
paediatric emergency
Additional relevant MeSH terms:
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Bacterial Infections
Emergencies
Fever
Disease Attributes
Pathologic Processes
Body Temperature Changes