Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Другое Automated fever alerts
  Fever alerts are automated sent to participants if fever is detected

Первичные конечные точки

• 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. [Срок оценки: 3 to 9 month per patient]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• Childrens' Clinc Bern, Inselspital Bern — Bern

Идентификаторы

NCT: NCT05940766 · Swiss 2024 Fever Monitoring

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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