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

Febrile Neutropenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

- 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Febrile Neutropenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Diagnostic Test:Evaluation of microbial translocation and microbiotaBlood test from catheter already in place to determine microbial translocation and stool sample taken for microbiota analysis

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Not yet recruiting

Start Date: November 2017

Completed Date: March 2019

Phase: N/A

Type: Observational

Design:

Primary Outcome: Evaluate the effect of presence of bacterial and fungal translocation on occurrence of episodes of febrile neutropenia in pediatric onco-hematology patients.

Secondary Outcome: Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia of unknown origin

Study sponsors, principal investigator, and references

Principal Investigator: Jean-Philippe Lavigne

Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Collaborator:

More information:https://clinicaltrials.gov/show/NCT03342365

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