Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

Study Overview
=================
Brief Summary
-----------------
In children and adolescents undergoing chemotherapy for cancer, fever in neutropenia (FN) is the most frequent potentially lethal complication of chemotherapy for cancer. Emergency hospitalization and empirical treatment with i.v. broad-spectrum antibiotics have reduced lethality from >50% in certain high risk situations to <1%. Fever without neutropenia is a further complication requiring emergency evaluation and often emergency treatment. Continuous monitoring of fever leads to earlier fever detection compared to the usual discrete fever measurements performed only for clinical reasons. Earlier detection of fever leads to earlier assessment and treatment and thus can reduce the risk of complications. This study primarily aims to assess, in pediatric patients undergoing chemotherapy for cancer, the efficacy of automated fever alerts resulting from continuous fever monitoring (CFM) using a wearable device (WD), measured by the duration of intravenous antibiotics (i.v. AB) given for any cause.

Detailed Description
-----------------
Primary objective The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer. Secondary objectives Regarding safety A. Number of fever episodes (FE) with safety relevant events (SREs) B. Number of false alerts C. Number of missed alarms Regarding efficacy D. Delay of chemotherapy application E. Duration of antimicrobial application except i.v. antibiotics F. Number of FEs diagnosed below or at temperature limit (TL) versus above TL G. FEs according to chemotherapy intensity H. WD measured core temperature at time of fever detection by ear thermometer I. FEs reported outside TARs J. Quality of life Questionnaire K. Assessment of the side-effects of the WD Tertiary objective L. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature M. Pattern search using data mining

Official Title
-----------------
Swiss 2024 Fever Monitoring Study: An Double-blinded, Randomized Controlled Multiple Crossover Superiority Trial on Continuous Fever Monitoring in Paediatric Patients With Cancer at Risk for Fever in Neutropenia

Conditions
-----------------
Pediatric Oncology Patients With Risk for Infections

Intervention / Treatment
-----------------
* Other: Automated fever alerts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chemotherapy treatment because of any malignancy expected to last ≥2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by hematopoietic stem cell transplantation Age ≥1 month and <18 years at time of recruitment Written informed consent from patients and/or parents Exclusion Criteria: Neonates <1 months Local skin disease prohibiting wearing of the WD Denied written informed consent from patients and/or parents Inclusion of vulnerable participants mandatory as vital signs and FN episodes differ significantly in children and adults

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention With CFM alerts arm<br>Routine clinical care, which includes, among others, discrete fever measurements using ear thermometers in case of clinical deterioration or suspected fever, at the discretion of patients where applicable, parents and the treating team Plus CFM with a CORE® WD running, with alerts being sent automatically to participants if the CFM detects an estimated core body temperature fulfilling the fever criterion of the respective study site (≥38.5°C or 39.0°C). | Other: Automated fever alerts<br>* Fever alerts are automated sent to participants if fever is detected<br>|
| No Intervention: Control Without CFM alerts arm<br>Routine clinical care as in With CFM alerts Plus CFM with a CORE® WD running as in With CFM alerts, but with alerts being sent only if a clinically dangerous temperature of ≥40.0°C is detected, which will very rarely be the case before fever is detected by routine clinical care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer. | The cumulative duration of i.v. antibiotics applied | 3 to 9 month per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fever episodes (FE) with safety relevant events (SREs) | Number of FE with SREs | 3 to 9 month per patient | 
| Number of false alerts | Number of false alerts | 3 to 9 month per patient | 
| Number of missed alarms | Number of missed alarms | 3 to 9 month per patient | 
| Delay of chemotherapy application | Duration of delay of chemotherapy application in days | 3 to 9 month per patient | 
| Duration of antimicrobial application except i.v. antibiotics | Duration of antimicrobial application except i.v. antibiotics | 3 to 9 month per patient | 
| Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL | Number of FEs diagnosed below or at TL versus above TL | 3 to 9 month per patient | 
| FEs according to chemotherapy intensity | Amount of fever episodes according to chemotherapy intensity | 3 to 9 month per patient | 
| Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer | WD measured core temperature at time of fever detection by ear thermometer | 3 to 9 month per patient | 
| FEs reported outside times of risk (TARs) | Amount of fever episodes reported outside TARs | 3 to 9 month per patient | 
| Quality of life Questionnaire | Proportion of participants indicating that wearing a WDs is acceptable/unacceptable, not increasing anxiety/increasing anxiety, providing/not providing security, increase burden/effort or not | Month 1, 6 and at study completion, an average of 1 year | 
| Assessment of the side-effects of the WD | Side effects reported by participants, if applicable | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fever, Neutropenia, Pediatric oncology, Core temperature, Wearable device, Continous monitoring, Automated alerts