Pediatric FN Definition 2012 Bern

Study Overview
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Brief Summary
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STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values, emergency calls and consultations for fever, and on hospitalizations for FN in children and adolescents with cancer to describe the frequency of episodes of FN, and of other clinically relevant FN-related measures to compare these frequencies and measures in reality vs. applying Bernese standard limits for defining fever (ear temperature ≥39.0°C) to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow) to determine if it would be useful to perform an interventional study on the question of different fever limits, powered to study both efficacy (frequency of FN) and safety (AE in delayed FN diagnosis) to use the platform of this prospective study to explore if the serum level of cortisol is associated with adverse events in FN HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°C to lower limits would increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint). increase the rate of other clinically important FN-related measures related to chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related measures during treatment of FN episodes diagnosed in reality (secondary endpoints 4,5,6). not relevantly decrease the proportion of FN with AE (secondary endpoint 7).

Official Title
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Pediatric FN Definition 2012 Bern The Impact of Lowering Fever Limits on the Rate of Fever in Chemotherapy-induced Neutropenia (FN). A Prospective Single-center Observational Study in Children and Adolescents With Cancer.

Conditions
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Cancer in Children/Adolescents, Fever in Neutropenia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >1 year and ≤17 years at time of recruitment Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment Written informed consent from patients and/or parents for the study Exclusion Criteria: Infants ≤1 year old (reason: differences in standard fever limit and method to measure temperature) Denied written informed consent from patients and/or parents for the study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Pediatric patients with cancer, receiving standard chemotherapy, and receiving standard supportive therapy in case of fever in neutropenia (FN) (No intervention for study purposes) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard) |  | until 2 weeks after last dose of chemotherapy (expected median, 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of episodes of fever | (Protocol: 1) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) | 
| Rate of emergency calls for fever | (Protocol: 2a) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) | 
| Rate ratio of FN diagnosed earlier (applying LimitLow vs. LimitStandard) | (Protocol: 3) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) | 
| Proportion of FN with blood cultures performed after start of antibiotics (AB) for prolonged fever | (Protocol: 4a) | until end of AB therapy for FN (estimated median, 4 days) | 
| Proportion of FN with delayed hospital discharge for prolonged fever | (Protocol: 5) (Low risk FN episodes with first-day stepping down will be excluded from this analysis.) | until end of AB therapy for FN (estimated median, 4 days) | 
| Time point of empirical AB switch for prolonged fever during FN | (Protocol: 6a) | until end of AB therapy for FN (estimated median, 4 days) | 
| Proportion of FN with any adverse event | (Protocol: 7a) | until end of AB therapy for FN (estimated median, 4 days) | 
| Serum level of cortisol | (Protocol: 8) | at presentation with FN (in reality) | 
| Proportion of FN with switch of empirical AB for prolonged fever | (Protocol: 4b) | until end of AB therapy for FN (estimated median, 4 days) | 
| Proportion of FN with add-on of empirical antifungal therapy for prolonged fever | (Protocol: 4c) | until end of AB therapy for FN (estimated median, 4 days) | 
| Rate of emergency CBC with consultation for fever | (Protocol: 2b) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) | 
| Time point of starting empirical antifungal therapy for prolonged fever during FN | (Protocol: 6b) | until end of AB therapy for FN (estimated median, 4 days) | 
| Proportion of FN with bacteremia | (Protocol: 7b) | until end of AB therapy for FN (estimated median, 4 days) | 
| Proportion of FN with serious medical complication | (Protocol: 7c) | until end of AB therapy for FN (estimated median, 4 days) |