Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

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

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Key information

Conditions

Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

Ligue contre le cancer, France
Ministry of Health, France

Registry information

Official study title

Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Feb 15, 2018
Registry last updated: Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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