An observational study in Febrile Neutropenia, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 3 sites in France. Open to participants aged 0 Years to 20 Years. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
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Among 16 studies in Febrile Neutropenia with a site in France — 1 open to participants now, 1 under way, 1 of them phase 3. Febrile Neutropenia · France.
Among the 16 studies in Febrile Neutropenia with a site in France, this one is the 10th largest by enrollment of the 10 observational ones that give a count, is one of 2 that started in 2018, is one of 10 observational ones, and was the 8th registered.
147 studies on the registry are indexed under Febrile Neutropenia; 36 are open to participants now.
Browse Febrile Neutropenia studies →1 of the 16 studies in Febrile Neutropenia with a site in France is open now. Recruiting first, the newest first:
Versailles Hospital · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 19 Febrile Neutropenia studies recruiting now, 11 (58%) set no upper age limit and 8 (42%) stop at 75 or younger; 4 take children under 18; none take healthy volunteers.
This study: 0 Years to 20 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 131 across 46 observational studies indexed under Febrile Neutropenia.
Median enrollment 484 across the 6 interventional studies, 122 across the 10 observational. Of the 14 that completed or were terminated, 2 (14%) have results posted.
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3 of 16 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 89 are open to participants now.
Centre Hospitalier Universitaire de Nīmes has 1 study filed under Febrile Neutropenia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Febrile Neutropenia with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Patients presenting to the CHU Nîmes onco-pediatric service with febrile neutropenia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Information concerning the study set-up, objectives, constraints and the patient's rights is transmitted
The patient is under state guardianship or safeguard of justice
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood test from catheter already in place to determine microbial translocation and stool sample taken for microbiota analysis
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.
Time frame: Between day 7-15
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
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
Compare bacterial and fungal translocation kinetics in febrile neutropenic patients of unknown origin versus bacteremic patients
Time frame: 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
Time frame: Between day 7-15
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
Time frame: Between day 7-15
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
Time frame: end of study day 30
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Dec 2018, 8 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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