Pediatric FN Definition 2012 Bern - Full Text View

Purpose

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).

Condition
Cancer in Children/Adolescents Fever in Neutropenia

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
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.

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Cancer Fever

U.S. FDA Resources

Further study details as provided by Swiss Pediatric Oncology Group:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of episodes of fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ] [ Designated as safety issue: No ]
(Protocol: 1)
Rate of emergency calls for fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ] [ Designated as safety issue: No ]
(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) ] [ Designated as safety issue: No ]
(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) ] [ Designated as safety issue: No ]
(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) ] [ Designated as safety issue: No ]
(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) ] [ Designated as safety issue: No ]
(Protocol: 6a)
Proportion of FN with any adverse event [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ] [ Designated as safety issue: No ]
(Protocol: 7a)
Serum level of cortisol [ Time Frame: at presentation with FN (in reality) ] [ Designated as safety issue: No ]
(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) ] [ Designated as safety issue: No ]
(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) ] [ Designated as safety issue: No ]
(Protocol: 4c)
Rate of emergency CBC with consultation for fever [ Time Frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months) ] [ Designated as safety issue: No ]
(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) ] [ Designated as safety issue: No ]
(Protocol: 6b)
Proportion of FN with bacteremia [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ] [ Designated as safety issue: No ]
(Protocol: 7b)
Proportion of FN with serious medical complication [ Time Frame: until end of AB therapy for FN (estimated median, 4 days) ] [ Designated as safety issue: No ]
(Protocol: 7c)

Biospecimen Retention: Samples Without DNA

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

Estimated Enrollment:	49
Study Start Date:	August 2012

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)

Eligibility

Ages Eligible for Study:	1 Year to 17 Years
Genders Eligible for Study:	Both
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683370

Contacts

Contact: Roland A Ammann, MD	0041 31 632 93 72	roland.ammann@insel.ch
Contact: Kurt Leibundgut, MD	0041 31 632 93 72	kurt.leibundgut@insel.ch

Locations

Switzerland
Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital	Recruiting
Bern, Switzerland, CH-3010
Contact: Roland A Ammann, MD 0041 31 632 93 72 roland.ammann@insel.ch
Contact: Kurt Leibundgut, MD 0041 31 632 93 72 kurt.leibundgut@insel.ch
Principal Investigator: Roland A Ammann, MD
Sub-Investigator: Kurt Leibundgut, MD
Sub-Investigator: Oliver Teuffel, MD
Sub-Investigator: Philipp Agyeman, MD
Sub-Investigator: Miriam Diepold, MD
Sub-Investigator: Sonja Lüer, MD
Sub-Investigator: Eva M Tinner, MD
Sub-Investigator: Nadine Amport, RN

Sponsors and Collaborators

Roland A. Ammann

Swiss Cancer League

Investigators

Study Chair:

Roland A Ammann, MD

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

More Information

No publications provided

Responsible Party:	Roland A. Ammann, Associate Professor, Swiss Pediatric Oncology Group
ClinicalTrials.gov Identifier:	NCT01683370 History of Changes
Other Study ID Numbers:	PFND2012B, KFS-2933-02-2012
Study First Received:	August 31, 2012
Last Updated:	December 19, 2012
Health Authority:	Switzerland: Kantonale Ethikkommission Bern

Additional relevant MeSH terms:

Fever
Neutropenia
Body Temperature Changes
Signs and Symptoms

Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013