TerminatedNot Applicable

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

Stopped: the difficulties encountered in including

France63 participantsStarted 2021-01-27

Plain-language 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.

Who can participate

Age range1 Year – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change in quality of life score, calculated from the PedsQL™ scale between inclusion and Day 6.

Timeframe: at day 6

Trial details

NCT IDNCT04938206

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-10