DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule

Neutropenia, Febrile Clinical Trial

— DISCERN-FN7  

Official title:

DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938206
• Other study ID #: 2018_99
• Secondary ID: 2019-A01025-52PR
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: François Dubos, MD,PhD
• Phone: (3) 20 44 59 20
• Email: francois.dubos[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Febrile neutropenia (NF) is the leading cause of unscheduled hospitalization in children with cancer. Management classically involves emergency admission to hospital for intravenous antibiotic treatment until resolution of fever and neutropenia. However, children with NF are a heterogeneous group with varying risks of severe infection (10-29%). This approach, which is recognized as excessive for low-risk episodes of severe infection, particularly in terms of quality of life and cost, is no longer recommended. Management should move to a more personalized model that takes into account the individual probability of severe infection. Clinical decision rules (CDRs) have been proposed to facilitate risk stratification, but none are useful in our French population because of insufficient reproducibility or effectiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1480
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Followed for hemopathy or cancer,

• Presenting with post-chemotherapy NF,

• With social security coverage,

• With parents able to provide appropriate home supervision,

• Consent of parents and child if able to give consent.

Exclusion Criteria:

• NF to diagnosis of tumor disease,

• Child with palliative care,

• Child who has had an allogeneic hematopoietic stem cell transplant within the past year,

• NF immediately following an autologous hematopoietic stem cell transplant,

• Participation in the study during a previous NF,

• Curative antibiotic therapy or documented infection prior to admission,

• Initial management at a non-investigative center,

• Refusal of the child or parents to participate

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Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Hyperthermia
• Neutropenia
• Neutropenia, Febrile

Intervention

Procedure:
• The Clinical Decision Rule
The Clinical Decision Rule will be applied to all patients included in the study at different times depending on the type of cancer: at H12-H24 of admission for patients with solid tumor; at H24-H48 for patients with hematological cancer. Patients classified as being at low risk of severe infection by the DRC were then randomized to a control group under standard management or to an experimental group with therapeutic relief. Treatment reduction for the experimental group was started immediately after randomization, in hospital. Discharge was proposed 24 hours later, with follow-up every two days, by telephone or in

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life score, calculated from the PedsQL™ scale between inclusion and Day 6.	The Pediatric Quality of Life Inventory (PedsQL) is a brief measure of health-related quality of life in children and young people. The measure can be completed by parents (the Proxy Report) as well as children and young people (the Self-Report).; On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).; To reverse score, transform the 0-4 scale items to 0-100 as follows: 0=100, 1=75, 2=50, 3=25, 4=0.	at day 6