Skip to main content
OpenTrials
Completed

NCT Number: NCT01683370

Pediatric FN Definition 2012 Bern

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer in Children/Adolescents Fever in Neutropenia Neoplasms

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital

Bern, CH-3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)

    Time frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

Secondary outcomes

  1. Rate of episodes of fever

    Time frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

    (Protocol: 1)

  2. Rate of emergency calls for fever

    Time frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

    (Protocol: 2a)

  3. Rate ratio of FN diagnosed earlier (applying LimitLow vs. LimitStandard)

    Time frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

    (Protocol: 3)

  4. Proportion of FN with blood cultures performed after start of antibiotics (AB) for prolonged fever

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 4a)

  5. Proportion of FN with delayed hospital discharge for prolonged fever

    Time frame: 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.)

  6. Time point of empirical AB switch for prolonged fever during FN

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 6a)

  7. Proportion of FN with any adverse event

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 7a)

  8. Serum level of cortisol

    Time frame: at presentation with FN (in reality)

    (Protocol: 8)

  9. Proportion of FN with switch of empirical AB for prolonged fever

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 4b)

  10. Proportion of FN with add-on of empirical antifungal therapy for prolonged fever

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 4c)

  11. Rate of emergency CBC with consultation for fever

    Time frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

    (Protocol: 2b)

  12. Time point of starting empirical antifungal therapy for prolonged fever during FN

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 6b)

  13. Proportion of FN with bacteremia

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 7b)

  14. Proportion of FN with serious medical complication

    Time frame: until end of AB therapy for FN (estimated median, 4 days)

    (Protocol: 7c)

Sponsors and collaborators

Lead sponsor

Dr. Roland Ammann

Other

Collaborators

  • Swiss Cancer League

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2012
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.