Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

NCT ID: NCT03434795

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Dubos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Jeanne de Flandre - CHRU de Lille

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 34871572 (View on PubMed)

Other Identifiers

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912180

Identifier Type: OTHER

Identifier Source: secondary_id

12-272

Identifier Type: OTHER

Identifier Source: secondary_id

2011_40

Identifier Type: -

Identifier Source: org_study_id

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