DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule (DISCERN-FN7)
Primary Purpose
Neutropenia, Febrile
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The Clinical Decision Rule
Sponsored by
About this trial
This is an interventional other trial for Neutropenia, Febrile
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)
Sites / Locations
- Hop Jeanne de Flandre Chu LilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
management reduction strategy
standard management
Arm Description
Patients classified as low risk by the DRC who will have a reduction in the management of their post-chemotherapy NF.
Patients classified as low risk by the DRC who will have standard management of post-chemotherapy NF.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04938206
First Posted
June 16, 2021
Last Updated
March 28, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT04938206
Brief Title
DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule
Acronym
DISCERN-FN7
Official Title
DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Febrile
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
management reduction strategy
Arm Type
Experimental
Arm Description
Patients classified as low risk by the DRC who will have a reduction in the management of their post-chemotherapy NF.
Arm Title
standard management
Arm Type
Active Comparator
Arm Description
Patients classified as low risk by the DRC who will have standard management of post-chemotherapy NF.
Intervention Type
Procedure
Intervention Name(s)
The Clinical Decision Rule
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in quality of life score, calculated from the PedsQL™ scale between inclusion and Day 6.
Description
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.
Time Frame
at day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Dubos, MD,PhD
Phone
(3) 20 44 59 20
Ext
+33
Email
francois.dubos@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Dubos, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Jeanne de Flandre Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
12. IPD Sharing Statement
Learn more about this trial
DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule
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