DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule (DISCERN-FN7)

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.

Study Overview

• Status: Recruiting
• Conditions: Neutropenia, Febrile
• Intervention / Treatment: Procedure: The Clinical Decision Rule

• Study Type: Interventional
• Enrollment (Anticipated): 1480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François Dubos, MD,PhD; Phone Number: +33 (3) 20 44 59 20; Email: francois.dubos@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

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

Description

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

Translated with www.DeepL.com/Translator (free version)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: management reduction strategy; Patients classified as low risk by the DRC who will have a reduction in the management of their post-chemotherapy NF.	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
Active Comparator: standard management; Patients classified as low risk by the DRC who will have standard management of post-chemotherapy NF.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: François Dubos, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Neutropenia; Hyperthermia; Fever; Febrile Neutropenia
• Other Study ID Numbers: 2018_99; 2019-A01025-52 (Other Identifier: ID-RCB number,ANSM); PREPS-18-0507 (Other Identifier: DGOS number)

Drug and device information, study documents

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