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Febrile NeutropeniaTRANSNEUTROFEBNCT03342365

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

An observational study of Febrile Neutropenia, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 0 to 20 years
Conditions the study is for
Febrile Neutropenia
What is being tested?
Evaluation of microbial translocation and microbiota
How many people
10 participants
Where
3 sitesFrance
Study dates
13 Apr 2018to 29 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients presenting to the CHU Nîmes onco-pediatric service with febrile neutropenia

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale

    Montpellier, 34093

  • CHU de Montpellier

    Montpellier, 342995

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About 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.

Being tested
Evaluation of microbial translocation and microbiota
Medical subject headings
Febrile Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of microbial translocation and microbiotaDiagnostic test

    Blood test from catheter already in place to determine microbial translocation and stool sample taken for microbiota analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Between day 7-15

Secondary outcomes (6)

  1. Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia of unknown origin

    Measured: Between day 7-15

  2. Evaluate prognostic quality of fungal and bacterial translocation markers in occurrence of episodes of febrile neutropenia in bacteremic patients

    Measured: Between day 7-15

  3. Compare bacterial and fungal translocation kinetics in febrile neutropenic patients of unknown origin versus bacteremic patients

    Measured: 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

    Measured: Between day 7-15

  5. Describe the kinetics of markers and intestinal microbial phylogenetic compositions according to the bioclinical characteristics of the population

    Diversity defined by number of different species and number of different taxonomic groups

    Measured: Between day 7-15

  6. Creation of biobank

    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

    Measured: end of study day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2017
  2. Study start13 Apr 2018
  3. Primary completion29 Dec 2018
  4. Study completion29 Dec 2018

Why it stopped: 10 patients inclued instead of 50

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03342365
Sponsor's protocol ID
LOCAL/2017/JPL-01
Acronym
TRANSNEUTROFEB
Status last verified
Jan 2021
First submitted
9 Nov 2017
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Febrile Neutropenia, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 10 patients inclued instead of 50). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03342365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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