Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

Insel Gruppe AG, University Hospital Bern

Status: Not yet enrolling

Conditions: Pediatric Oncology Patients With Risk for Infections

Treatments: Other: Automated fever alerts

Study type: Interventional

Funder types: Other

Identifiers

NCT05940766

Swiss 2024 Fever Monitoring

Details and patient eligibility

About

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.

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Intervention "With CFM alerts" arm

Experimental group

Description:

* 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).

Treatment:

Other: Automated fever alerts

Control "Without CFM alerts" arm

No Intervention group

Description:

* 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.