Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

NCT03434795 | Completed

• 3 other identifiers: 2011_4091218012-272
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

Outcome Measures

Primary Outcomes (4)

• Blood culture

  Presence or not of bacteriemia

  On average between 5 days and 1 month

• Positive bacterial culture from a normally sterile site

  Presence or not of bacterial infection

  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

  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

  On average between 5 days and 1 month

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator
• Ligue contre le cancer, France: collaborator

Study Sites (1)

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 34871572 RESULT

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• François Dubos, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 15, 2018
• Study Start: May 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 22, 2026

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)