Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology
Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology
Sponsors
Source
Centre Hospitalier Universitaire de Nīmes
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
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.
Overall Status
Not yet recruiting
Start Date
2018-01-01
Completion Date
2019-05-01
Primary Completion Date
2019-05-01
Phase
N/A
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Evaluate the effect of presence of bacterial and fungal translocation on occurrence of episodes of febrile neutropenia in pediatric onco-hematology patients. |
Between day 7-15 |
Secondary Outcome
Measure |
Time Frame |
|
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 |
|
Creation of biobank |
end of study day 30 |
Number Of Groups
1
Enrollment
50
Condition
Intervention
Intervention Type
Diagnostic Test
Intervention Name
Description
Blood test from catheter already in place to determine microbial translocation and stool sample taken for microbiota analysis
Eligibility
Study Pop
Patients presenting to the CHU Nîmes onco-pediatric service with febrile neutropenia
Sampling Method
Non-Probability Sample
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 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
Gender
All
Minimum Age
N/A
Maximum Age
20 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Jean-Philippe Lavigne |
Principal Investigator |
CHU Nimes |
Overall Contact
Location
Facility | |||
|
UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale Montpellier 34093 France | |||
|
CHU de Montpellier Montpellier 342995 France | |||
|
CHU Nimes Nîmes 30029 France |
Not yet recruiting |
Last Name: Jean-Philippe Lavigne, MD Role: Principal Investigator Last Name: Quentin Chevrier, MD Role: Sub-Investigator Last Name: Géraldine Lavigne, MD Role: Sub-Investigator Last Name: Catherine Dunyach-Remy, MD Role: Sub-Investigator Last Name: Hélène Marchandin, MD Role: Sub-Investigator |
Location Countries
Country
France
Verification Date
2017-11-01
Lastchanged Date
2017-12-14
Firstreceived Date
2017-11-09
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Biospec Retention
Samples With DNA
Biospec Descr
Blood samples and stool samples
Acronym
TRANSNEUTROFEB
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Only
Time Perspective
Prospective
Study First Submitted
November 9, 2017
Study First Submitted Qc
November 9, 2017
Study First Posted
November 14, 2017
Last Update Submitted
December 14, 2017
Last Update Submitted Qc
December 14, 2017
Last Update Posted
December 15, 2017
ClinicalTrials.gov processed this data on December 15, 2017
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.