Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology

Study Overview
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Brief Summary
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This pilot study aims to study intestinal bacterial and fungal translocation and the evolution of the intestinal microbiota in patients over the course of their medical surveillance to search for a link between dysbiosis and bacterial/fungal translocation, but also to better understand the elements involved in febrile episodes in these patients (lack of detection of blood microorganisms, translocation of constituent elements of these microorganisms, etc.). We hypothesize that the composition of the intestinal microbiota as well as the phenomenon of intestinal microbial translocation will have an influence on the occurrence of fever and/or bacteremia in neutropenic patients hospitalized in pediatric onco-hematology.

Official Title
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Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology

Conditions
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Febrile Neutropenia

Intervention / Treatment
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* Diagnostic Test: Evaluation of microbial translocation and microbiota


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Information concerning the study set-up, objectives, constraints and the patient's rights is transmitted The patient and/or their legal guardian must have given their free and informed consent. If the patient is over 18, it is the patient who signs the consent form The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: The patient is under state guardianship or safeguard of justice Refusal to sign the consent It is impossible to give the subject informed information Pregnant, parturient or breast feeding patient

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Evaluation of microbial translocation and microbiota|Blood test from catheter already in place to determine microbial translocation and stool sample taken for microbiota analysis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of presence of bacterial and fungal translocation on occurrence of episodes of febrile neutropenia in pediatric onco-hematology patients. | Presence or absence of microbial translocation; presence = ≥ 10 copies of rDNA16S/µL and/or ≥ 1 copies rDNA 18S/µL and ≥10 ng/mL LBP, ≥10 ng/mL of sCD14 and ≥5 ng/mL of zonulin. | Between day 7-15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia of unknown origin |  | Between day 7-15 | 
| Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia in bacteremic patients |  | Between day 7-15 | 
| Compare bacterial and fungal translocation kinetics in febrile neutropenic patients of unknown origin versus bacteremic patients |  | Between day 7-15 | 
| Compare direct (16S rDNA, 18S rDNA) versus indirect (LBP, sCD14 and plasma zonulin) measures of translocation and association with bioclinical characteristics of the population |  | Between day 7-15 | 
| Describe the kinetics of markers and intestinal microbial phylogenetic compositions according to the bioclinical characteristics of the population | Diversity defined by number of different species and number of different taxonomic groups | Between day 7-15 | 
| Creation of biobank | All blood and stool samples taken from patients who develop neutropenia. Patients who do not develop neutropenia will have their samples collected at inclusion destroyed | end of study day 30 |