NCT05940766 Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
| NCT ID | NCT05940766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Pediatric Oncology Patients With Risk for Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-02-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Eva K Brack, MD, PhD
PRINCIPAL INVESTIGATOR
Childrens' Clinic Bern, Inselspital, Bern
Frequently Asked Questions
Who can join the NCT05940766 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 17 Years, studying Pediatric Oncology Patients With Risk for Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05940766 currently recruiting?
Yes, NCT05940766 is actively recruiting participants. Contact the research team at eva.brack@insel.ch for enrollment information.
Where is the NCT05940766 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT05940766 clinical trial?
NCT05940766 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Eva K Brack, MD, PhD at Childrens' Clinic Bern, Inselspital, Bern. The trial plans to enroll 250 participants.