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

University Hospital, Lille

Status: Terminated

Conditions: Neutropenia, Febrile

Treatments: Procedure: The Clinical Decision Rule

Study type: Interventional

Funder types: Other

Identifiers

NCT04938206

2019-A01025-52 (Other Identifier)

2018_99

PREPS-18-0507 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

management reduction strategy

Experimental group

Description:

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

Treatment:

Procedure: The Clinical Decision Rule

standard management

Active Comparator group

Description:

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

Treatment:

Procedure: The Clinical Decision Rule