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

NCT04938206 | Terminated

• 3 other identifiers: 2018_992019-A01025-52PREPS-18-0507
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neutropenia, Febrile

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

management reduction strategy

EXPERIMENTAL

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

standard management

ACTIVE COMPARATOR

Patients classified as low risk by the DRC who will have standard management of post-chemotherapy NF.

Procedure: The Clinical Decision Rule

Interventions

The Clinical Decision Rule PROCEDURE

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

management reduction strategy; standard management

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• François Dubos, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: January 27, 2021
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

FR (1)