Clinical trial NCT03342365: Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology
Official title: Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Febrile Neutropenia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the CHU Nîmes onco-pediatric service with febrile neutropenia

Brief summary: 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.


Eligibility criteria: * 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

Primary outcomes:
measure: Evaluate the effect of presence of bacterial and fungal translocation on occurrence of episodes of febrile neutropenia in pediatric onco-hematology patients.
timeFrame: Between day 7-15
Secondary outcomes:
measure: Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia of unknown origin
timeFrame: Between day 7-15
measure: Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia in bacteremic patients
timeFrame: Between day 7-15
measure: Compare bacterial and fungal translocation kinetics in febrile neutropenic patients of unknown origin versus bacteremic patients
timeFrame: Between day 7-15
measure: Compare direct (16S rDNA, 18S rDNA) versus indirect (LBP, sCD14 and plasma zonulin) measures of translocation and association with bioclinical characteristics of the population
timeFrame: Between day 7-15
measure: Describe the kinetics of markers and intestinal microbial phylogenetic compositions according to the bioclinical characteristics of the population
timeFrame: Between day 7-15
measure: Creation of biobank
timeFrame: end of study day 30
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Jean-Philippe Lavigne
role: PRINCIPAL_INVESTIGATOR
References: