Febrile Neutropenia, Rule of Clinical Decision, ChemotherapyNCT03434795
Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy
An observational study of Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy, run by University Hospital, Lille at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy
- How many people
- 1,900 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to May 2017
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient with hematology or cancer who consults for febrile neutropenia post-chemotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule
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
- Medical subject headings
- Febrile Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood culture
Presence or not of bacteriemia
Measured: On average between 5 days and 1 month
Positive bacterial culture from a normally sterile site
Presence or not of bacterial infection
Measured: on average between 5 days and 1 month
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
Measured: On average between 5 days and 1 month
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
Measured: On average between 5 days and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study startMay 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Febrile Neutropenia, Rule of Clinical Decision, ChemotherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- François Dubos, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434795
- Sponsor's protocol ID
- 2011_40
- Other IDs
- 912180, 12-272
- Status last verified
- Feb 2018
- First submitted
- 18 Jan 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule
- ClinicalTrials.gov ID
- NCT03434795
- Acronym / sponsor ID
- 2011_40
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Ligue contre le cancer, France
- Study start
- May 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient with hematology or cancer who consults for febrile neutropenia post-chemotherapy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood culture
Time frame: On average between 5 days and 1 month
Presence or not of bacteriemia
Positive bacterial culture from a normally sterile site
Time frame: on average between 5 days and 1 month
Presence or not of bacterial infection
microbiological culture
Time frame: On average between 5 days and 1 month
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
Fungal culture
Time frame: On average between 5 days and 1 month
Presence or not of fungal infection is referred to a proven, probable, or possible fungal infection as defined by the IFICG ot the EORTC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 34871572Delebarre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Dubos, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy, run by University Hospital, Lille at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood culture (time frame: On average between 5 days and 1 month). The study lists 4 primary outcomes in all. 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 NCT03434795, which also lists 1 linked publication.
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 22 Apr 2026.