Pediatric FN Definition 2012 Bern
29 ottobre 2020 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Tipo di studio
Osservativo
Iscrizione (Effettivo)
39
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bern, Svizzera, CH-3010
- Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 anno a 17 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Rate of episodes of fever
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Roland A Ammann, MD, Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2012
Completamento primario (Effettivo)
1 agosto 2013
Completamento dello studio (Effettivo)
1 agosto 2013
Date di iscrizione allo studio
Primo inviato
31 agosto 2012
Primo inviato che soddisfa i criteri di controllo qualità
7 settembre 2012
Primo Inserito (Stima)
11 settembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 novembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PFND2012B
- KFS-2933-02-2012 (Altro numero di sovvenzione/finanziamento: Krebsforschung Schweiz)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .