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

Febrile Neutropenia Clinical Trial

— TRANSNEUTROFEB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03342365
• Other study ID #: LOCAL/2017/JPL-01
• Status: Terminated
• Start date: April 13, 2018
• Est. completion date: December 29, 2018

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 29, 2018
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia

Intervention

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

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia of unknown origin		Between day 7-15
Secondary	Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia in bacteremic patients		Between day 7-15
Secondary	Compare bacterial and fungal translocation kinetics in febrile neutropenic patients of unknown origin versus bacteremic patients		Between day 7-15
Secondary	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
Secondary	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
Secondary	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