Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

Sponsor

Insel Gruppe AG, University Hospital Bern (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05940766

Collaborator

ETH Zurich (Other)

250

Enrollment

Location

Arms

44.9

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Oncology Patients With Risk for Infections	Other: Automated fever alerts	N/A

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

Number of fever episodes (FE) with safety relevant events (SREs)
Number of false alerts
Number of missed alarms

Regarding efficacy

Delay of chemotherapy application
Duration of antimicrobial application except i.v. antibiotics
Number of FEs diagnosed below or at temperature limit (TL) versus above TL
FEs according to chemotherapy intensity
WD measured core temperature at time of fever detection by ear thermometer
FEs reported outside TARs
Quality of life Questionnaire
Assessment of the side-effects of the WD

Tertiary objective

Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature
Pattern search using data mining

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trialProspective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial

Masking:

Double (Participant, Investigator)

Masking Description:

Double-blinded

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Oct 1, 2024

Anticipated Primary Completion Date :

May 31, 2028

Anticipated Study Completion Date :

Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention "With CFM alerts" arm 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 Fever alerts are automated sent to participants if fever is detected
No Intervention: Control "Without CFM alerts" arm 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.

Arm

Intervention/Treatment

Experimental: Intervention "With CFM alerts" arm

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

Fever alerts are automated sent to participants if fever is detected

No Intervention: Control "Without CFM alerts" arm

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.

Outcome Measures

Primary Outcome Measures

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. [3 to 9 month per patient]
The cumulative duration of i.v. antibiotics applied

Secondary Outcome Measures

Number of fever episodes (FE) with safety relevant events (SREs) [3 to 9 month per patient]
Number of FE with SREs
Number of false alerts [3 to 9 month per patient]
Number of false alerts
Number of missed alarms [3 to 9 month per patient]
Number of missed alarms
Delay of chemotherapy application [3 to 9 month per patient]
Duration of delay of chemotherapy application in days
Duration of antimicrobial application except i.v. antibiotics [3 to 9 month per patient]
Duration of antimicrobial application except i.v. antibiotics
Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL [3 to 9 month per patient]
Number of FEs diagnosed below or at TL versus above TL
FEs according to chemotherapy intensity [3 to 9 month per patient]
Amount of fever episodes according to chemotherapy intensity
Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer [3 to 9 month per patient]
WD measured core temperature at time of fever detection by ear thermometer
FEs reported outside times of risk (TARs) [3 to 9 month per patient]
Amount of fever episodes reported outside TARs
Quality of life Questionnaire [Month 1, 6 and at study completion, an average of 1 year]
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
Assessment of the side-effects of the WD [Through study completion, an average of 1 year]
Side effects reported by participants, if applicable

Other Outcome Measures

Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature [Through study completion, an average of 1 year]
Difference between discrete measurements of core temperature
Vital sign pattern search in monitored core temperature using data mining [Through study completion, an average of 1 year]
Exploration of potential changes in or specific patterns of all measured temperature signals within 48 hours before clinical diagnosis of fever

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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