Clinical trial · Observational
Pediatric FN Definition 2012 Bern
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer in Children/Adolescents | — | UNRESOLVED | — |
| Fever in Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Pediatric patients with cancer, receiving standard chemotherapy, and receiving standard supportive therapy in case of fever in neutropenia (FN) (No intervention for study purposes)
Primary outcomes (1)
- measure
- Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)
- timeFrame
- until 2 weeks after last dose of chemotherapy (expected median, 6 months)
Secondary outcomes (14)
- measure
- Rate of episodes of fever
- timeFrame
- until 2 weeks after last dose of chemotherapy (expected median, 6 months)
- description
- (Protocol: 1)
- measure
- Rate of emergency calls for fever
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTAmmann 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. PMID 25671574
- RESULTWagner 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. PMID 29462193
- RESULTBrack 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. PMID 32457478
- RESULTLavieri 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. PMID 31270328