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

NCT03342365 | Terminated

• 1 other identifier: LOCAL/2017/JPL-01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  Between day 7-15

Interventions

Evaluation of microbial translocation and microbiota DIAGNOSTIC_TEST

Blood test from catheter already in place to determine microbial translocation and stool sample taken for microbiota analysis

Eligibility Criteria

• Age: 0 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the CHU Nîmes onco-pediatric service with febrile neutropenia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale

Montpellier, 34093, France

Location

CHU de Montpellier

Montpellier, 342995, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and stool samples

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Jean-Philippe Lavigne

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: April 13, 2018
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2018
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)