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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 3 to 9 month per patient
The cumulative duration of i.v. antibiotics applied
次要结局
- Number of false alerts(3 to 9 month per patient)
- Delay of chemotherapy application(3 to 9 month per patient)
- Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer(3 to 9 month per patient)
- Quality of life Questionnaire(Month 1, 6 and at study completion, an average of 1 year)
- Duration of antimicrobial application except i.v. antibiotics(3 to 9 month per patient)
- FEs reported outside times of risk (TARs)(3 to 9 month per patient)
- Number of fever episodes (FE) with safety relevant events (SREs)(3 to 9 month per patient)
- Number of missed alarms(3 to 9 month per patient)
- Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL(3 to 9 month per patient)
- FEs according to chemotherapy intensity(3 to 9 month per patient)
- Assessment of the side-effects of the WD(Through study completion, an average of 1 year)