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

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ClinicalTrials.gov Identifier: NCT03342365
Recruitment Status : Terminated (10 patients inclued instead of 50)
First Posted : November 14, 2017
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Febrile Neutropenia Diagnostic Test: Evaluation of microbial translocation and microbiota

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology
Actual Study Start Date : April 13, 2018
Actual Primary Completion Date : December 29, 2018
Actual Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Molds


Intervention Details:
  • 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


Primary Outcome Measures :
  1. Evaluate the effect of presence of bacterial and fungal translocation on occurrence of episodes of febrile neutropenia in pediatric onco-hematology patients. [ Time Frame: 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 :
  1. Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia of unknown origin [ Time Frame: Between day 7-15 ]
  2. Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia in bacteremic patients [ Time Frame: Between day 7-15 ]
  3. Compare bacterial and fungal translocation kinetics in febrile neutropenic patients of unknown origin versus bacteremic patients [ Time Frame: Between day 7-15 ]
  4. Compare direct (16S rDNA, 18S rDNA) versus indirect (LBP, sCD14 and plasma zonulin) measures of translocation and association with bioclinical characteristics of the population [ Time Frame: Between day 7-15 ]
  5. Describe the kinetics of markers and intestinal microbial phylogenetic compositions according to the bioclinical characteristics of the population [ Time Frame: Between day 7-15 ]
    Diversity defined by number of different species and number of different taxonomic groups

  6. Creation of biobank [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Blood samples and stool samples


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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the CHU Nîmes onco-pediatric service with febrile neutropenia
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342365


Locations
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France
UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale
Montpellier, France, 34093
CHU de Montpellier
Montpellier, France, 342995
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Jean-Philippe Lavigne CHU Nimes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03342365    
Other Study ID Numbers: LOCAL/2017/JPL-01
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes