Clinical trial NCT05940766: Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Oncology Patients With Risk for Infections
Keywords: Fever
Neutropenia
Pediatric oncology
Core temperature
Wearable device
Continous monitoring
Automated alerts
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2023-07-11
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: 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.
timeFrame: 3 to 9 month per patient
Secondary outcomes:
measure: Number of fever episodes (FE) with safety relevant events (SREs)
timeFrame: 3 to 9 month per patient
measure: Number of false alerts
timeFrame: 3 to 9 month per patient
measure: Number of missed alarms
timeFrame: 3 to 9 month per patient
measure: Delay of chemotherapy application
timeFrame: 3 to 9 month per patient
measure: Duration of antimicrobial application except i.v. antibiotics
timeFrame: 3 to 9 month per patient
measure: Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL
timeFrame: 3 to 9 month per patient
measure: FEs according to chemotherapy intensity
timeFrame: 3 to 9 month per patient
measure: Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer
timeFrame: 3 to 9 month per patient
measure: FEs reported outside times of risk (TARs)
timeFrame: 3 to 9 month per patient
measure: Quality of life Questionnaire
timeFrame: Month 1, 6 and at study completion, an average of 1 year
measure: Assessment of the side-effects of the WD
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature
timeFrame: Through study completion, an average of 1 year
measure: Vital sign pattern search in monitored core temperature using data mining
timeFrame: Through study completion, an average of 1 year
Locations:
city: Bern
country: Switzerland
facility: Childrens' Clinc Bern, Inselspital Bern
Study officials:
affiliation: Childrens' Clinic Bern, Inselspital, Bern
name: Eva K Brack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: