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

Terminated

• Conditions: Febrile Neutropenia

• Registration Number: NCT03342365
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2018-04-13
• Primary Completion: 2018-12-29
• Study Completion: 2018-12-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of presence of bacterial and fungal translocation on occurrence of episodes of febrile neutropenia in pediatric onco-hematology patients.	Between day 7-15	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.

Secondary Outcome Measures

Name	Time	Method
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
Creation of biobank	end of study day 30	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
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	Between day 7-15	Diversity defined by number of different species and number of different taxonomic groups

Trial Locations

Locations (3)

UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale; 🇫🇷 Montpellier, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France