Pediatric FN Definition 2012 Bern
2020年10月29日 更新者：Dr. Roland Ammann
Pediatric FN Definition 2012 Bern The Impact of Lowering Fever Limits on the Rate of Fever in Chemotherapy-induced Neutropenia (FN). A Prospective Single-center Observational Study in Children and Adolescents With Cancer.
STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values, emergency calls and consultations for fever, and on hospitalizations for FN in children and adolescents with cancer
- to describe the frequency of episodes of FN, and of other clinically relevant FN-related measures
- to compare these frequencies and measures in reality vs. applying Bernese standard limits for defining fever (ear temperature ≥39.0°C)
- to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow)
- to determine if it would be useful to perform an interventional study on the question of different fever limits, powered to study both efficacy (frequency of FN) and safety (AE in delayed FN diagnosis)
- to use the platform of this prospective study to explore if the serum level of cortisol is associated with adverse events in FN
HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°C to lower limits would
- increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint).
- increase the rate of other clinically important FN-related measures related to chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related measures during treatment of FN episodes diagnosed in reality (secondary endpoints 4,5,6).
- not relevantly decrease the proportion of FN with AE (secondary endpoint 7).
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
39
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Bern、瑞士、CH-3010
- Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Pediatric patients diagnosed with cancer requiring chemotherapy, treated at the Division of Pediatric Hematology/Oncology, Department of Pediatric, University of Bern / Inselspital, CH-3010 Bern, Switzerland
描述
Inclusion Criteria:
- >1 year and ≤17 years at time of recruitment
- Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment
- Written informed consent from patients and/or parents for the study
Exclusion Criteria:
- Infants ≤1 year old (reason: differences in standard fever limit and method to measure temperature)
- Denied written informed consent from patients and/or parents for the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Patients
Pediatric patients with cancer, receiving standard chemotherapy, and receiving standard supportive therapy in case of fever in neutropenia (FN) (No intervention for study purposes)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)
大体时间：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of episodes of fever
大体时间：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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(Protocol: 1)
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until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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Rate of emergency calls for fever
大体时间：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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(Protocol: 2a)
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until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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Rate ratio of FN diagnosed earlier (applying LimitLow vs. LimitStandard)
大体时间：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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(Protocol: 3)
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until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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Proportion of FN with blood cultures performed after start of antibiotics (AB) for prolonged fever
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 4a)
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until end of AB therapy for FN (estimated median, 4 days)
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Proportion of FN with delayed hospital discharge for prolonged fever
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 5) (Low risk FN episodes with first-day stepping down will be excluded from this analysis.)
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until end of AB therapy for FN (estimated median, 4 days)
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Time point of empirical AB switch for prolonged fever during FN
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 6a)
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until end of AB therapy for FN (estimated median, 4 days)
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Proportion of FN with any adverse event
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 7a)
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until end of AB therapy for FN (estimated median, 4 days)
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Serum level of cortisol
大体时间：at presentation with FN (in reality)
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(Protocol: 8)
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at presentation with FN (in reality)
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Proportion of FN with switch of empirical AB for prolonged fever
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 4b)
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until end of AB therapy for FN (estimated median, 4 days)
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Proportion of FN with add-on of empirical antifungal therapy for prolonged fever
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 4c)
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until end of AB therapy for FN (estimated median, 4 days)
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Rate of emergency CBC with consultation for fever
大体时间：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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(Protocol: 2b)
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until 2 weeks after last dose of chemotherapy (expected median, 6 months)
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Time point of starting empirical antifungal therapy for prolonged fever during FN
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 6b)
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until end of AB therapy for FN (estimated median, 4 days)
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Proportion of FN with bacteremia
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 7b)
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until end of AB therapy for FN (estimated median, 4 days)
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Proportion of FN with serious medical complication
大体时间：until end of AB therapy for FN (estimated median, 4 days)
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(Protocol: 7c)
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until end of AB therapy for FN (estimated median, 4 days)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Roland A Ammann, MD、Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ammann RA, Teuffel O, Agyeman P, Amport N, Leibundgut K. The influence of different fever definitions on the rate of fever in neutropenia diagnosed in children with cancer. PLoS One. 2015 Feb 11;10(2):e0117528. doi: 10.1371/journal.pone.0117528. eCollection 2015.
- Wagner S, Brack EK, Stutz-Grunder E, Agyeman P, Leibundgut K, Teuffel O, Ammann RA. The influence of different fever definitions on diagnostics and treatment after diagnosis of fever in chemotherapy-induced neutropenia in children with cancer. PLoS One. 2018 Feb 20;13(2):e0193227. doi: 10.1371/journal.pone.0193227. eCollection 2018.
- Brack E, Wagner S, Stutz-Grunder E, Agyeman PKA, Ammann RA. Temperatures, diagnostics and treatment in pediatric cancer patients with fever in neutropenia, NCT01683370. Sci Data. 2020 May 26;7(1):156. doi: 10.1038/s41597-020-0504-9.
- Lavieri L, Koenig C, Teuffel O, Agyeman P, Ammann RA. Temperatures and blood counts in pediatric patients treated with chemotherapy for cancer, NCT01683370. Sci Data. 2019 Jul 3;6(1):108. doi: 10.1038/s41597-019-0112-8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年8月1日
初级完成 (实际的)
2013年8月1日
研究完成 (实际的)
2013年8月1日
研究注册日期
首次提交
2012年8月31日
首先提交符合 QC 标准的
2012年9月7日
首次发布 (估计)
2012年9月11日
研究记录更新
最后更新发布 (实际的)
2020年11月2日
上次提交的符合 QC 标准的更新
2020年10月29日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.