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CompletedNCT03434795Updated Apr 22, 2026

Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

An observational study in Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,900
Ages
1 Year to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

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.

Enrollment
Largest of 10
1,900 · median 122
Started
2012
the only one that year
Observational
10 of 16
none open now
Registered
10th of 16
by date
Lead sponsor
2 of 16
University Hospital, Lille

Among the 16 studies in Febrile Neutropenia with a site in France, this one has the largest enrollment of the 10 observational ones that give a count, is the only one that started in 2012, is one of 10 observational ones, and was the 10th registered.

Febrile Neutropenia

147 studies on the registry are indexed under Febrile Neutropenia; 36 are open to participants now.

Browse Febrile Neutropenia studies →

Open to participants now

1 of the 16 studies in Febrile Neutropenia with a site in France is open now. Recruiting first, the newest first:

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 →

Who these studies take

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: 1 Year to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia

03

Conditions studied

  • Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

Browse trials for

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient with hematology or cancer who consults for febrile neutropenia post-chemotherapy

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.

Inclusion criteria

  • Child aged 1 to 18 years
  • Child with hematology or cancer
  • Child with a febrile neutropenia post-chemotherapy
  • Child with social security
  • No opposition from the child and/or parents, in case of absence, the holder of the parental authority present, can consent, alone, to the participation of the unemancipated minor.

Exclusion criteria

Exclusion Criteria:

  • Febrile neutropenia at diagnosis of tumor disease
  • Child with palliative care
  • Child having had a hematopoietic stem cell allo-graft in the preceding year
  • Febrile neutropenia immediately post auto-transplant
  • Antibiotherapy prior to admission
  • Initial care in a non-investigative center.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,900 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Blood culture

    Presence or not of bacteriemia

    Time frame: On average between 5 days and 1 month

  2. Positive bacterial culture from a normally sterile site

    Presence or not of bacterial infection

    Time frame: on average between 5 days and 1 month

  3. microbiological culture

    Presence or not of focal infection at high risk of dissemination was defined as any local infection with or without microbiological documentation into a normally sterile site, with significant risk of loco-regional or systemic spread

    Time frame: On average between 5 days and 1 month

  4. Fungal culture

    Presence or not of fungal infection is referred to a proven, probable, or possible fungal infection as defined by the IFICG ot the EORTC

    Time frame: On average between 5 days and 1 month

07

Study locations

1 site
  • Hôpital Jeanne de Flandre - CHRU de Lille
    Lille, France
08

References and documents

Publications

  • Delebarre M, Gonzales F, Behal H, Tiphaine A, Sudour-Bonnange H, Lutun A, Abbou S, Pertuisel S, Thouvenin-Doulet S, Pellier I, Mansuy L, Piguet C, Paillard C, Blanc L, Thebaud E, Plantaz D, Blouin P, Schneider P, Guillaumat C, Simon P, Domenech C, Pacquement H, Le Meignen M, Pluchart C, Verite C, Plat G, Martinot A, Duhamel A, Dubos F. Decision-tree derivation and external validation of a new clinical decision rule (DISCERN-FN) to predict the risk of severe infection during febrile neutropenia in children treated for cancer. Lancet Child Adolesc Health. 2022 Apr;6(4):260-268. doi: 10.1016/S2352-4642(21)00337-0. Epub 2021 Dec 3. PubMed 34871572 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of May 2017 and a completion of May 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2018
First posted
Feb 15, 2018
Start
May 2012
Primary completionActual
May 2017
CompletionActual
May 2017
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03434795
Collaborators
Ministry of Health, France, Ligue contre le cancer, France
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
May 2012
Primary completion
May 2017
Completion
May 2017
Last update
Apr 22, 2026

Study contacts

François Dubos, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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