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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01025-52 | Other Identifier | ID-RCB number,ANSM | |
| PREPS-18-0507 | Other Identifier | DGOS number |
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the difficulties encountered in including
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| management reduction strategy | Experimental | Patients classified as low risk by the DRC who will have a reduction in the management of their post-chemotherapy NF. |
|
| standard management | Active Comparator | Patients classified as low risk by the DRC who will have standard management of post-chemotherapy NF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Clinical Decision Rule | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at day 6 |
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Inclusion Criteria:
Exclusion Criteria:
Translated with www.DeepL.com/Translator (free version)
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| Name | Affiliation | Role |
|---|---|---|
| François Dubos, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Jeanne de Flandre Chu Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |