Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

Completed

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

• Registration Number: NCT03434795
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Study First Submitted: 2018-01-18
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-13
• Last Update Submitted: 2018-02-13
• Study First Posted: 2018-02-15
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1900

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Hôpital Jeanne de Flandre - CHRU de Lille; 🇫🇷 Lille, France