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| Name | Class |
|---|---|
| ETH Zurich | OTHER |
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In children and adolescents undergoing chemotherapy for cancer, fever in neutropenia (FN) is the most frequent potentially lethal complication of chemotherapy for cancer. Emergency hospitalization and empirical treatment with i.v. broad-spectrum antibiotics have reduced lethality from >50% in certain high risk situations to <1%. Fever without neutropenia is a further complication requiring emergency evaluation and often emergency treatment.
Continuous monitoring of fever leads to earlier fever detection compared to the usual discrete fever measurements performed only for clinical reasons. Earlier detection of fever leads to earlier assessment and treatment and thus can reduce the risk of complications.
This study primarily aims to assess, in pediatric patients undergoing chemotherapy for cancer, the efficacy of automated fever alerts resulting from continuous fever monitoring (CFM) using a wearable device (WD), measured by the duration of intravenous antibiotics (i.v. AB) given for any cause.
Primary objective
The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer.
Secondary objectives
Regarding safety
A. Number of fever episodes (FE) with safety relevant events (SREs)
B. Number of false alerts
C. Number of missed alarms
Regarding efficacy
D. Delay of chemotherapy application
E. Duration of antimicrobial application except i.v. antibiotics
F. Number of FEs diagnosed below or at temperature limit (TL) versus above TL
G. FEs according to chemotherapy intensity
H. WD measured core temperature at time of fever detection by ear thermometer
I. FEs reported outside TARs
J. Quality of life Questionnaire
K. Assessment of the side-effects of the WD
Tertiary objective
L. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature
M. Pattern search using data mining
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention "With CFM alerts" arm | Experimental |
|
|
| Control "Without CFM alerts" arm | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated fever alerts | Other | Fever alerts are automated sent to participants if fever is detected |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer. | The cumulative duration of i.v. antibiotics applied | 3 to 9 month per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Number of fever episodes (FE) with safety relevant events (SREs) | Number of FE with SREs | 3 to 9 month per patient |
| Number of false alerts | Number of false alerts |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature | Difference between discrete measurements of core temperature | Through study completion, an average of 1 year |
| Vital sign pattern search in monitored core temperature using data mining |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva K Brack, MD, PhD | Contact | +41316641943 | eva.brack@insel.ch | |
| Roland Ammann, MD, Prof. | Contact | info@statconsultammann.ch |
| Name | Affiliation | Role |
|---|---|---|
| Eva K Brack, MD, PhD | Childrens' Clinic Bern, Inselspital, Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens' Clinc Bern, Inselspital Bern | Bern | 2010 | Switzerland |
Publication in international journal of study protocol and results
End of study
All study information will be made publically available as long as the patient as signed the informed consent for data sharing
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| ID | Term |
|---|---|
| D005334 | Fever |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000380 | Agranulocytosis |
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Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial
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Double-blinded
| 3 to 9 month per patient |
| Number of missed alarms | Number of missed alarms | 3 to 9 month per patient |
| Delay of chemotherapy application | Duration of delay of chemotherapy application in days | 3 to 9 month per patient |
| Duration of antimicrobial application except i.v. antibiotics | Duration of antimicrobial application except i.v. antibiotics | 3 to 9 month per patient |
| Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL | Number of FEs diagnosed below or at TL versus above TL | 3 to 9 month per patient |
| FEs according to chemotherapy intensity | Amount of fever episodes according to chemotherapy intensity | 3 to 9 month per patient |
| Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer | WD measured core temperature at time of fever detection by ear thermometer | 3 to 9 month per patient |
| FEs reported outside times of risk (TARs) | Amount of fever episodes reported outside TARs | 3 to 9 month per patient |
| Quality of life Questionnaire | Proportion of participants indicating that wearing a WDs is acceptable/unacceptable, not increasing anxiety/increasing anxiety, providing/not providing security, increase burden/effort or not | Month 1, 6 and at study completion, an average of 1 year |
| Assessment of the side-effects of the WD | Side effects reported by participants, if applicable | Through study completion, an average of 1 year |
Exploration of potential changes in or specific patterns of all measured temperature signals within 48 hours before clinical diagnosis of fever |
| Through study completion, an average of 1 year |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |