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CompletedNCT01683370Updated Nov 2, 2020

Pediatric FN Definition 2012 Bern

An observational study in Cancer in Children/Adolescents and Fever in Neutropenia, sponsored by Dr. Roland Ammann. Completed at 1 site in Switzerland. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by Dr. Roland Ammann · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
39
Ages
1 Year to 17 Years
Sex
All
01

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).
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Conditions studied

  • Cancer in Children/Adolescents
  • Fever in Neutropenia

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03

In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 39 is below the median of 175 across 96 observational studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

This is the only study on the registry with Dr. Roland Ammann as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
39 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

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What researchers measure

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

    (Protocol: 1)

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

  2. Rate of emergency calls for fever

    (Protocol: 2a)

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

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

    (Protocol: 3)

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

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

    (Protocol: 4a)

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

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

    (Protocol: 5) (Low risk FN episodes with first-day stepping down will be excluded from this analysis.)

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

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

    (Protocol: 6a)

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

  7. Proportion of FN with any adverse event

    (Protocol: 7a)

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

  8. Serum level of cortisol

    (Protocol: 8)

    Time frame: at presentation with FN (in reality)

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

    (Protocol: 4b)

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

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

    (Protocol: 4c)

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

  11. Rate of emergency CBC with consultation for fever

    (Protocol: 2b)

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

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

    (Protocol: 6b)

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

  13. Proportion of FN with bacteremia

    (Protocol: 7b)

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

  14. Proportion of FN with serious medical complication

    (Protocol: 7c)

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

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Study locations

1 site
  • Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital
    Bern, CH-3010, Switzerland
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References and documents

Publications

  • 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. PubMed 25671574 ↗
  • 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. PubMed 29462193 ↗
  • 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. PubMed 32457478 ↗
  • 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. PubMed 31270328 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01683370
Lead sponsor
Dr. Roland Ammann
Collaborators
Swiss Cancer League
Responsible party
Dr. Roland Ammann (Associate Professor, Swiss Pediatric Oncology Group) — Sponsor-investigator
First posted
Sep 11, 2012
Start date
Aug 2012
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Nov 2, 2020

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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