Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-25 @ 2:28 PM
Study NCT ID:
NCT05940766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-11
First Post:
2023-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Swiss 2024 Fever Monitoring Study: An Double-blinded, Randomized Controlled Multiple Crossover Superiority Trial on Continuous Fever Monitoring in Paediatric Patients With Cancer at Risk for Fever in Neutropenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: