Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
- Conditions
- Pediatric Oncology Patients With Risk for Infections
- Interventions
- Other: Automated fever alerts
- Registration Number
- NCT05940766
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention "With CFM alerts" arm Automated fever alerts * 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of false alerts 3 to 9 month per patient Number of false alerts
Delay of chemotherapy application 3 to 9 month per patient Duration of delay of chemotherapy application in days
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
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
Duration of antimicrobial application except i.v. antibiotics 3 to 9 month per patient Duration of antimicrobial application except i.v. antibiotics
FEs reported outside times of risk (TARs) 3 to 9 month per patient Amount of fever episodes reported outside TARs
Number of fever episodes (FE) with safety relevant events (SREs) 3 to 9 month per patient Number of FE with SREs
Number of missed alarms 3 to 9 month per patient Number of missed alarms
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
Assessment of the side-effects of the WD Through study completion, an average of 1 year Side effects reported by participants, if applicable
Trial Locations
- Locations (1)
Childrens' Clinc Bern, Inselspital Bern
🇨🇭Bern, Switzerland