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

NCT ID: NCT04938206

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2024-10-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

management reduction strategy

Patients classified as low risk by the DRC who will have a reduction in the management of their post-chemotherapy NF.

Group Type: EXPERIMENTAL

The Clinical Decision Rule

Intervention Type: 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

standard management

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

Group Type: ACTIVE_COMPARATOR

The Clinical Decision Rule

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Dubos, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Jeanne de Flandre Chu Lille

Lille, , France

Countries

France

Other Identifiers

2019-A01025-52

Identifier Type: OTHER

Identifier Source: secondary_id

PREPS-18-0507

Identifier Type: OTHER

Identifier Source: secondary_id

2018_99

Identifier Type: -

Identifier Source: org_study_id