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.

Overall Status

Not yet recruiting

Start Date

2017-11-01

Completion Date

2019-03-01

Primary Completion Date

2019-03-01

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

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

Last Name

Jean-Philippe Lavigne

Phone

04.66.68.32.02

Email



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: Anissa Megzari
Phone: +33 (0)4.66.68.42.36
Email: [email protected]
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

2017-11-09

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

November 9, 2017

Last Update Submitted Qc

November 9, 2017

Last Update Posted

November 14, 2017


ClinicalTrials.gov processed this data on November 14, 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.



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