Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

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

Study Overview

• Status: Completed
• Conditions: Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 1900

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Jeanne de Flandre - CHRU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France; Ligue contre le cancer, France
• Investigators: Principal Investigator: François Dubos, MD, PhD, University Hospital, Lille

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Leukocyte Disorders; Hematologic Diseases; Leukopenia; Agranulocytosis; Neutropenia; Hemic and Lymphatic Diseases; Febrile Neutropenia
• Other Study ID Numbers: 2011_40; 912180 (Other Identifier: CNIL number); 12-272 (Other Identifier: CCTIRS number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No