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Pediatric FN Definition 2012 Bern

29. oktober 2020 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

39

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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)

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dr. Roland Ammann

Samarbejdspartnere

Swiss Cancer League

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2012

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

31. august 2012

Først indsendt, der opfyldte QC-kriterier

7. september 2012

Først opslået (Skøn)

11. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PFND2012B
  • KFS-2933-02-2012 (Andet bevillings-/finansieringsnummer: Krebsforschung Schweiz)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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