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

NCT04938206 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-12-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • François Dubos, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2024-10-10
Completion
2024-10-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938206 on ClinicalTrials.gov