Pediatric FN Definition 2012 Bern

NCT01683370 | Completed

• 2 other identifiers: PFND2012BKFS-2933-02-2012
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (14)

• Rate of episodes of fever

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

• Rate of emergency calls for fever

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

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

  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

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

• Proportion of FN with delayed hospital discharge for prolonged fever

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

Study Arms (1)

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)

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Roland Ammann: lead
• Swiss Cancer League: collaborator

Study Sites (1)

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

Bern, CH-3010, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 25671574 RESULT

• 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.

  PMID: 29462193 RESULT

• 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.

  PMID: 32457478 RESULT

• 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.

  PMID: 31270328 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 mL serum, kept refrigerated until the end of study, then analyed as batch for cortisol, then discarded.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Roland A Ammann, MD

  Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 11, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

CH (1)