Pediatric Oncology Patients With Risk for InfectionsNCT05940766
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
A study testing Automated fever alerts in people with Pediatric Oncology Patients With Risk for Infections, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Pediatric Oncology Patients With Risk for Infections
- What is being tested?
- Automated fever alerts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roland Ammann, MD, Prof. contact
Switzerland1 site, 1 recruiting
- Recruiting
Childrens' Clinc Bern, Inselspital Bern
Bern, 2010
Eva K Brack, MD, MD-PhD, eva.brack@insel.ch
Roland Ammann, MD, Prof, info@statconsultammann.ch
About this study
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
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.
Read the 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
- Number of fever episodes (FE) with safety relevant events (SREs)
- Number of false alerts
- Number of missed alarms
Regarding efficacy
- Delay of chemotherapy application
- Duration of antimicrobial application except i.v. antibiotics
- Number of FEs diagnosed below or at temperature limit (TL) versus above TL
- FEs according to chemotherapy intensity
- WD measured core temperature at time of fever detection by ear thermometer
- FEs reported outside TARs
- Quality of life Questionnaire
- Assessment of the side-effects of the WD
Tertiary objective
- Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature
- Pattern search using data mining
- Being tested
- Automated fever alerts
- Keywords
- Fever, Neutropenia, Pediatric oncology, Core temperature, Wearable device, Continous monitoring, Automated alerts
- Medical subject headings
- Fever, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated fever alertsOther
Fever alerts are automated sent to participants if fever is detected
| Study group | Role | What they receive |
|---|---|---|
| Intervention "With CFM alerts" arm | Experimental | * Routine clinical care, which includes, among others, discrete fever measurements using ear thermometers in case of clinical deterioration or suspected fever, at the discretion of patients where applicable, parents and the treating team
* Plus CFM with a CORE® WD running, with alerts being sent automatically to participants if the CFM detects an estimated core body temperature fulfilling the fever criterion of the respective study site (≥38.5°C or 39.0°C). Receives: Other: Automated fever alerts |
| Control "Without CFM alerts" arm | No intervention | * Routine clinical care as in "With CFM alerts" * Plus CFM with a CORE® WD running as in "With CFM alerts", but with alerts being sent only if a clinically dangerous temperature of ≥40.0°C is detected, which will very rarely be the case before fever is detected by routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 to 9 month per patient
Secondary outcomes (11)
Number of fever episodes (FE) with safety relevant events (SREs)
Number of FE with SREs
Measured: 3 to 9 month per patient
Number of false alerts
Number of false alerts
Measured: 3 to 9 month per patient
Number of missed alarms
Number of missed alarms
Measured: 3 to 9 month per patient
Delay of chemotherapy application
Duration of delay of chemotherapy application in days
Measured: 3 to 9 month per patient
Duration of antimicrobial application except i.v. antibiotics
Duration of antimicrobial application except i.v. antibiotics
Measured: 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
Measured: 3 to 9 month per patient
FEs according to chemotherapy intensity
Amount of fever episodes according to chemotherapy intensity
Measured: 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
Measured: 3 to 9 month per patient
FEs reported outside times of risk (TARs)
Amount of fever episodes reported outside TARs
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Feb 2025
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Oncology Patients With Risk for InfectionsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Eva K Brack, MD, PhD, Principal investigator, Childrens' Clinic Bern, Inselspital, Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940766
- Sponsor's protocol ID
- Swiss 2024 Fever Monitoring
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in international journal of study protocol and results
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05940766
- Acronym / sponsor ID
- Swiss 2024 Fever Monitoring
- Keywords
- Fever, Neutropenia, Pediatric oncology, Core temperature, Wearable device, Continous monitoring, Automated alerts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Number of fever episodes (FE) with safety relevant events (SREs)
- Number of false alerts
- Number of missed alarms
Regarding efficacy
- Delay of chemotherapy application
- Duration of antimicrobial application except i.v. antibiotics
- Number of FEs diagnosed below or at temperature limit (TL) versus above TL
- FEs according to chemotherapy intensity
- WD measured core temperature at time of fever detection by ear thermometer
- FEs reported outside TARs
- Quality of life Questionnaire
- Assessment of the side-effects of the WD
Tertiary objective
- Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature
- Pattern search using data mining
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial
| Arm | Type | Receives |
|---|---|---|
| Intervention "With CFM alerts" arm | Experimental | Other: Automated fever alerts* Routine clinical care, which includes, among others, discrete fever measurements using ear thermometers in case of clinical deterioration or suspected fever, at the discretion of patients where applicable, parents and the treating team * Plus CFM with a CORE® WD running, with alerts being sent automatically to participants if the CFM detects an estimated core body temperature fulfilling the fever criterion of the respective study site (≥38.5°C or 39.0°C). |
| Control "Without CFM alerts" arm | No intervention | –* Routine clinical care as in "With CFM alerts" * Plus CFM with a CORE® WD running as in "With CFM alerts", but with alerts being sent only if a clinically dangerous temperature of ≥40.0°C is detected, which will very rarely be the case before fever is detected by routine clinical care. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated fever alertsFever alerts are automated sent to participants if fever is detected | Other | Intervention "With CFM alerts" arm |
Primary outcome
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.
Time frame: 3 to 9 month per patient
The cumulative duration of i.v. antibiotics applied
11 secondary outcomes
Number of fever episodes (FE) with safety relevant events (SREs)
Time frame: 3 to 9 month per patient
Number of false alerts
Time frame: 3 to 9 month per patient
Number of missed alarms
Time frame: 3 to 9 month per patient
Delay of chemotherapy application
Time frame: 3 to 9 month per patient
Duration of antimicrobial application except i.v. antibiotics
Time frame: 3 to 9 month per patient
Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL
Time frame: 3 to 9 month per patient
FEs according to chemotherapy intensity
Time frame: 3 to 9 month per patient
Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer
Time frame: 3 to 9 month per patient
FEs reported outside times of risk (TARs)
Time frame: 3 to 9 month per patient
Quality of life Questionnaire
Time frame: Month 1, 6 and at study completion, an average of 1 year
Assessment of the side-effects of the WD
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Publication in international journal of study protocol and results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland Ammann, MD, Prof. contact
Eva K Brack, MD, PhD principal investigator
Childrens' Clinic Bern, Inselspital, Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated fever alerts in people with Pediatric Oncology Patients With Risk for Infections, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva K Brack, MD, PhD (+41316641943, eva.brack@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 to 9 month per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.