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Trial Title:
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
NCT ID:
NCT05940766
Condition:
Pediatric Oncology Patients With Risk for Infections
Conditions: Official terms:
Neoplasms
Fever
Conditions: Keywords:
Fever
Neutropenia
Pediatric oncology
Core temperature
Wearable device
Continous monitoring
Automated alerts
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
Prospective interventional, multi-center, double-blinded, randomized controlled, multiple
crossover superiority trial
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Masking description:
Double-blinded
Intervention:
Intervention type:
Other
Intervention name:
Automated fever alerts
Description:
Fever alerts are automated sent to participants if fever is detected
Arm group label:
Intervention "With CFM alerts" arm
Summary:
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.
Detailed description:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Chemotherapy treatment because of any malignancy expected to last ≥2 months at time
of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative
chemotherapy followed by hematopoietic stem cell transplantation
- Age ≥1 month and <18 years at time of recruitment
- Written informed consent from patients and/or parents
Exclusion Criteria:
- Neonates <1 months
- Local skin disease prohibiting wearing of the WD
- Denied written informed consent from patients and/or parents
- Inclusion of vulnerable participants mandatory as vital signs and FN episodes differ
significantly in children and adults
Gender:
All
Minimum age:
1 Month
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Childrens' Clinc Bern, Inselspital Bern
Address:
City:
Bern
Zip:
2010
Country:
Switzerland
Contact:
Last name:
Eva K Brack, MD, MD-PhD
Email:
eva.brack@insel.ch
Contact backup:
Last name:
Roland Ammann, MD, Prof
Email:
info@statconsultammann.ch
Start date:
October 1, 2024
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
ETH Zurich
Agency class:
Other
Source:
Insel Gruppe AG, University Hospital Bern
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05940766
