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
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?
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
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.
Not yet recruiting
Start Date: November 2017
Completed Date: March 2019
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