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NCT Number: NCT05940766

Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

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.

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Key information

Conditions

Pediatric Oncology Patients With Risk for Infections Agranulocytosis Body Temperature Changes Cytopenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens' Clinc Bern, Inselspital Bern

Bern, 2010, Switzerland

Location contact

Eva K Brack, MD, MD-PhD

CONTACT

[email protected]

Roland Ammann, MD, Prof

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated fever alerts

Other

Fever alerts are automated sent to participants if fever is detected

Primary outcomes

  1. 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.

    Time frame: 3 to 9 month per patient

    The cumulative duration of i.v. antibiotics applied

Secondary outcomes

  1. Number of fever episodes (FE) with safety relevant events (SREs)

    Time frame: 3 to 9 month per patient

    Number of FE with SREs

  2. Number of false alerts

    Time frame: 3 to 9 month per patient

    Number of false alerts

  3. Number of missed alarms

    Time frame: 3 to 9 month per patient

    Number of missed alarms

  4. Delay of chemotherapy application

    Time frame: 3 to 9 month per patient

    Duration of delay of chemotherapy application in days

  5. Duration of antimicrobial application except i.v. antibiotics

    Time frame: 3 to 9 month per patient

    Duration of antimicrobial application except i.v. antibiotics

  6. Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL

    Time frame: 3 to 9 month per patient

    Number of FEs diagnosed below or at TL versus above TL

  7. FEs according to chemotherapy intensity

    Time frame: 3 to 9 month per patient

    Amount of fever episodes according to chemotherapy intensity

  8. Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer

    Time frame: 3 to 9 month per patient

    WD measured core temperature at time of fever detection by ear thermometer

  9. FEs reported outside times of risk (TARs)

    Time frame: 3 to 9 month per patient

    Amount of fever episodes reported outside TARs

  10. Quality of life Questionnaire

    Time frame: 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

  11. Assessment of the side-effects of the WD

    Time frame: Through study completion, an average of 1 year

    Side effects reported by participants, if applicable

Other outcomes

  1. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature

    Time frame: Through study completion, an average of 1 year

    Difference between discrete measurements of core temperature

  2. Vital sign pattern search in monitored core temperature using data mining

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eva K Brack, MD, PhD

CONTACT

[email protected]

+41316641943

Roland Ammann, MD, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • ETH Zurich

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2023
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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