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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03434795

Enrollment

1900

Registered

2018-02-15

Start date

2012-05-01

Completion date

2017-05-01

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood culture	On average between 5 days and 1 month	Presence or not of bacteriemia
Positive bacterial culture from a normally sterile site	on average between 5 days and 1 month	Presence or not of bacterial infection
microbiological culture	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	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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFrançois Dubos, MD, PhD

University Hospital, Lille

Outcome results