- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01683370
Pediatric FN Definition 2012 Bern
29 oktober 2020 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
39
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Bern, Schweiz, CH-3010
- Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)
Tidsram: until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
until 2 weeks after last dose of chemotherapy (expected median, 6 months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Rate of episodes of fever
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: until end of AB therapy for FN (estimated median, 4 days)
|
(Protocol: 7c)
|
until end of AB therapy for FN (estimated median, 4 days)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Roland A Ammann, MD, Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2012
Primärt slutförande (Faktisk)
1 augusti 2013
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
31 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
7 september 2012
Första postat (Uppskatta)
11 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 november 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PFND2012B
- KFS-2933-02-2012 (Annat bidrag/finansieringsnummer: Krebsforschung Schweiz)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Feber vid neutropeni
-
University of Mississippi Medical CenterOkändBarncancer | Kemoterapi-inducerad febril neutropeni | Kemoterapi-inducerad neutropeni | Granulocytkolonistimulerande faktorFörenta staterna
-
Institut RafaelAktiv, inte rekryterandePatientnöjdhet | Patientpreferens | Febril neutropeni, läkemedelsinduceradFrankrike
-
TTY BiopharmAvslutad
-
Hospira, now a wholly owned subsidiary of PfizerAvslutadFasta tumörer | Malign hemopati | Kemoterapi-inducerad febril neutropeni (FN)Frankrike
-
CinnagenAvslutadKemoterapi-inducerad neutropeni
-
University Hospital, BrestAvslutadNeutropeni, feberFrankrike
-
PfizerAvslutadNon-Interventional StudyTyskland
-
University Hospital Inselspital, BerneAvslutadFebril neutropeni | Barncancer | Onkologi | Kemoterapi-inducerad neutropeniSchweiz
-
BeyondSpring Pharmaceuticals Inc.AvslutadKemoterapi-inducerad neutropeniKina, Ryska Federationen, Förenta staterna, Ukraina
-
Jiangsu T-Mab Biopharma Co.,LtdAvslutadKemoterapi-inducerad neutropeniKina