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).
調査の概要
研究の種類
観察的
入学 (実際)
39
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Bern、スイス、CH-3010
- Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
1年～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
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)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)
時間枠：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of episodes of fever
時間枠：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
(Protocol: 1)
|
until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
|
Rate of emergency calls for fever
時間枠：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
(Protocol: 2a)
|
until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
|
Rate ratio of FN diagnosed earlier (applying LimitLow vs. LimitStandard)
時間枠：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
(Protocol: 3)
|
until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
|
Proportion of FN with blood cultures performed after start of antibiotics (AB) for prolonged fever
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 4a)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Proportion of FN with delayed hospital discharge for prolonged fever
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 5) (Low risk FN episodes with first-day stepping down will be excluded from this analysis.)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Time point of empirical AB switch for prolonged fever during FN
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 6a)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Proportion of FN with any adverse event
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 7a)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Serum level of cortisol
時間枠：at presentation with FN (in reality)
|
(Protocol: 8)
|
at presentation with FN (in reality)
|
|
Proportion of FN with switch of empirical AB for prolonged fever
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 4b)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Proportion of FN with add-on of empirical antifungal therapy for prolonged fever
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 4c)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Rate of emergency CBC with consultation for fever
時間枠：until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
(Protocol: 2b)
|
until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
|
Time point of starting empirical antifungal therapy for prolonged fever during FN
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 6b)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Proportion of FN with bacteremia
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 7b)
|
until end of AB therapy for FN (estimated median, 4 days)
|
|
Proportion of FN with serious medical complication
時間枠：until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 7c)
|
until end of AB therapy for FN (estimated median, 4 days)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Roland A Ammann, MD、Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年8月1日
一次修了 (実際)
2013年8月1日
研究の完了 (実際)
2013年8月1日
試験登録日
最初に提出
2012年8月31日
QC基準を満たした最初の提出物
2012年9月7日
最初の投稿 (見積もり)
2012年9月11日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月2日
QC基準を満たした最後の更新が送信されました
2020年10月29日
最終確認日
2020年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
好中球減少症における発熱の臨床試験
-
Zagazig University積極的、募集していないGrade III Traumatic Splenic Injury in Hemodynamically Stable Patientsエジプト
-
Hospital Universitario Doctor Pesetわからない
-
Food and Drug Administration (FDA)United States Department of Defense; National Eye Institute (NEI); United States Naval Medical...完了
-
Food and Drug Administration (FDA)National Eye Institute (NEI)完了
-
Mahmoud Hussein Bahr完了( 4 in 1 ブロック ) & ( 内転筋管ブロック ) による鎮痛効果の比較エジプト
-
Cairo University募集脊柱起立面ブロック | 小児科 | サーモグラフィ | 予測 | 赤外線 | 片側in径ヘルニア手術エジプト
-
Assistance Publique - Hôpitaux de Paris完了
-
Hoang Minh Ngan16A Ha Dong General Hospital募集