- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01683370
Pediatric FN Definition 2012 Bern
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).
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Bern, Svájc, CH-3010
- Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Rate of episodes of fever
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Tanulmányi szék: Roland A Ammann, MD, Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- PFND2012B
- KFS-2933-02-2012 (Egyéb támogatási/finanszírozási szám: Krebsforschung Schweiz)
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