Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time device was worn
研究概览
简要总结
The THERMAL study is a pilot study to determine feasibility of using two separate continuous skin temperature monitors during intensive treatment for haematological malignancies. It involves participants wearing both the TempTraq and CORE temperature devices for up to 14 days, and then assessing their feasibility and tolerability with quantitative, semiquantitative and qualitative methods.
详细描述
Patients with haematological malignancies such as leukaemia, lymphoma and myeloma often require intensive treatments such as chemotherapy, stem cell transplantation (either autologous or allogeneic) or CAR T-cell therapy. All these therapies can lead to a period of prolonged neutropenia, or low neutrophils, when they are at very high risk of serious bacterial infections. While other countries use routine prophylactic antibiotics, Australasian practice is to focus on prompt recognition and treatment of infections. There is clear evidence that early recognition and treatment of febrile neutropenia with antibiotics leads to improved outcomes, with each hour delay in antibiotic administration associated with an 18% increase in mortality.
Current practice is to detect fevers by both routine and symptom-based intermittent ear thermometer testing, with routine monitoring being approximately every four hours. However, neutropenic patients may not develop symptoms before manifesting a fever, meaning that continuous temperature monitoring could potentially lead to earlier recognition and treatment of febrile neutropenia.
This pilot study seeks to determine the feasibility of using two separate continuous skin temperature monitors during intensive treatment for haematological malignancies, in the inpatient and outpatient setting. If feasible, this could be used to increase the amount of treatments that can be safely performed as outpatients, as well as allowing earlier identification and treatment of febrile neutropenia.
The two proposed measuring devices are: 1. TempTraq adhesive temperature sensor, a skin temperature sensor which is applied to the axilla for 72 hours, then replaced; and 2. CORE temperature sensor, a rechargeable skin temperature sensor that is attached to the chest with a chest strap.
The TempTraq device is an FDA cleared class 2 medical device, while the CORE temperature monitor has received emergency FDA approval as a medical device in the context of the COVID-19 pandemic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-75 years
- •Diagnosis of acute leukaemia, lymphoma or myeloma by consultant haematologist or multidisciplinary meeting discussion
- •Undergoing treatment with either induction chemotherapy, autologous stem cell transplant, allogeneic stem cell transplant, or chimeric antigen receptor (CAR) T-cell therapy as part of their normal care.
排除标准
- •Medical condition that would result in discomfort from the application of chest or axillary monitoring.
- •Allergy to a component of the monitoring devices
- •Diminished capacity or any circumstance that would prohibit them from understanding and providing informed consent in accordance with ICH-GCP (International Conference on Harmonisation, Good Clinical Practice) principles.
结局指标
主要结局
Time device was worn
时间窗: 14 days
Percentage of time that both CORE and TempTraq were worn against total time available
次要结局
- Participant ethnicity(14 days)
- Participant diagnosis(14 days)
- Participant body mass index(14 days)
- Haematological treatment that participant is undergoing during study period(14 days)
- Device usability based on System Usability Scale questionnaire(12 days)
- Participant interest in device, based on Intrinsic Motivation Index questionnaire(12 days)
- Participant preference for TempTraq or CORE device(14 days)
- Comparability to intermittent ear thermometer data(14 days)
- Time between fever identification(14 days)
- Rates of skin irritation or infection(14 days)
- Participant age in years(14 days)