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Pediatric FN Definition 2012 Bern

NCT01683370 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2020-11-02

No results posted yet for this study

Summary

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).

Conditions

  • Cancer in Children/Adolescents
  • Fever in Neutropenia

Sponsors & Collaborators

  • Swiss Cancer League

    collaborator OTHER

  • Dr. Roland Ammann

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01683370 on ClinicalTrials.gov