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Pediatric FN Definition 2012 Bern

29. oktober 2020 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

39

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Bern, Sveits, CH-3010
        • Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)
Tidsramme: until 2 weeks after last dose of chemotherapy (expected median, 6 months)
until 2 weeks after last dose of chemotherapy (expected median, 6 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of episodes of fever
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: until end of AB therapy for FN (estimated median, 4 days)
(Protocol: 7c)
until end of AB therapy for FN (estimated median, 4 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dr. Roland Ammann

Samarbeidspartnere

Swiss Cancer League

Etterforskere

  • Studiestol: Roland A Ammann, MD, Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2012

Primær fullføring (Faktiske)

1. august 2013

Studiet fullført (Faktiske)

1. august 2013

Datoer for studieregistrering

Først innsendt

31. august 2012

Først innsendt som oppfylte QC-kriteriene

7. september 2012

Først lagt ut (Anslag)

11. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PFND2012B
  • KFS-2933-02-2012 (Annet stipend/finansieringsnummer: Krebsforschung Schweiz)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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