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Pediatric FN Definition 2012 Bern

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ClinicalTrials.gov Identifier: NCT01683370
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Swiss Cancer League
Information provided by (Responsible Party):
Dr. Roland Ammann, Swiss Pediatric Oncology Group

Tracking Information
First Submitted Date August 31, 2012
First Posted Date September 11, 2012
Last Update Posted Date May 7, 2018
Study Start Date August 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2012)
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) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01683370 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 11, 2012)
  • Rate of episodes of fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ]
    (Protocol: 1)
  • Rate of emergency calls for fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ]
    (Protocol: 2a)
  • 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)
  • 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)
  • 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.)
  • 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)
  • Proportion of FN with any adverse event [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
    (Protocol: 7a)
  • Serum level of cortisol [ Time Frame: at presentation with FN (in reality) ]
    (Protocol: 8)
  • 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)
  • 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)
  • Rate of emergency CBC with consultation for fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ]
    (Protocol: 2b)
  • 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)
  • Proportion of FN with bacteremia [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
    (Protocol: 7b)
  • Proportion of FN with serious medical complication [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
    (Protocol: 7c)
Original Secondary Outcome Measures
 (submitted: September 7, 2012)
  • 1. Rate of episodes of fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ]
  • 2a. Rate of emergency calls for fever [ 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) [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ]
  • 4a. 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) ]
  • 5. Proportion of FN with delayed hospital discharge for prolonged fever [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
    (Lowrisk FN episodes with first-day stepping down will be excluded from this analysis.)
  • 6a. Time point of empirical AB switch for prolonged fever during FN [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
  • 7a. Proportion of FN with any adverse event [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
  • 8. Serum level of cortisol [ Time Frame: at presentation with FN (in reality) ]
  • 4b. Proportion of FN with switch of empirical AB for prolonged fever [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
  • 4c. 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) ]
  • 2b. Rate of emergency CBC with consultation for fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ]
  • 6b. 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) ]
  • 7b. Proportion of FN with bacteremia [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
  • 7c. Proportion of FN with serious medical complication [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric FN Definition 2012 Bern
Official 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.
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
1 mL serum, kept refrigerated until the end of study, then analyed as batch for cortisol, then discarded.
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
Condition
  • Cancer in Children/Adolescents
  • Fever in Neutropenia
Intervention Not Provided
Study Groups/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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2013)
39
Original Estimated Enrollment
 (submitted: September 7, 2012)
49
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01683370
Other Study ID Numbers PFND2012B
KFS-2933-02-2012 ( Other Grant/Funding Number: Krebsforschung Schweiz )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Roland Ammann, Swiss Pediatric Oncology Group
Study Sponsor Dr. Roland Ammann
Collaborators Swiss Cancer League
Investigators
Study Chair: Roland A Ammann, MD Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland
PRS Account Swiss Pediatric Oncology Group
Verification Date May 2018