Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-26 @ 8:24 PM
Study NCT ID:
NCT05940766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-11
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D009503', 'term': 'Neutropenia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Difference between discrete measurements of core temperature'}, {'measure': 'Vital sign pattern search in monitored core temperature using data mining', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Exploration of potential changes in or specific patterns of all measured temperature signals within 48 hours before clinical diagnosis of fever'}], 'primaryOutcomes': [{'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.', 'timeFrame': '3 to 9 month per patient', 'description': 'The cumulative duration of i.v. antibiotics applied'}], 'secondaryOutcomes': [{'measure': 'Number of fever episodes (FE) with safety relevant events (SREs)', 'timeFrame': '3 to 9 month per patient', 'description': 'Number of FE with SREs'}, {'measure': 'Number of false alerts', 'timeFrame': '3 to 9 month per patient', 'description': 'Number of false alerts'}, {'measure': 'Number of missed alarms', 'timeFrame': '3 to 9 month per patient', 'description': 'Number of missed alarms'}, {'measure': 'Delay of chemotherapy application', 'timeFrame': '3 to 9 month per patient', 'description': 'Duration of delay of chemotherapy application in days'}, {'measure': 'Duration of antimicrobial application except i.v. antibiotics', 'timeFrame': '3 to 9 month per patient', 'description': 'Duration of antimicrobial application except i.v. antibiotics'}, {'measure': 'Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL', 'timeFrame': '3 to 9 month per patient', 'description': 'Number of FEs diagnosed below or at TL versus above TL'}, {'measure': 'FEs according to chemotherapy intensity', 'timeFrame': '3 to 9 month per patient', 'description': 'Amount of fever episodes according to chemotherapy intensity'}, {'measure': 'Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer', 'timeFrame': '3 to 9 month per patient', 'description': 'WD measured core temperature at time of fever detection by ear thermometer'}, {'measure': 'FEs reported outside times of risk (TARs)', 'timeFrame': '3 to 9 month per patient', 'description': 'Amount of fever episodes reported outside TARs'}, {'measure': 'Quality of life Questionnaire', 'timeFrame': 'Month 1, 6 and at study completion, an average of 1 year', 'description': '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'}, {'measure': 'Assessment of the side-effects of the WD', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Side effects reported by participants, if applicable'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fever', 'Neutropenia', 'Pediatric oncology', 'Core temperature', 'Wearable device', 'Continous monitoring', 'Automated alerts'], 'conditions': ['Pediatric Oncology Patients With Risk for Infections']}, 'descriptionModule': {'briefSummary': '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.\n\nContinuous 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.\n\nThis 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.', 'detailedDescription': 'Primary objective\n\nThe 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.\n\nSecondary objectives\n\nRegarding safety\n\nA. Number of fever episodes (FE) with safety relevant events (SREs)\n\nB. Number of false alerts\n\nC. Number of missed alarms\n\nRegarding efficacy\n\nD. Delay of chemotherapy application\n\nE. Duration of antimicrobial application except i.v. antibiotics\n\nF. Number of FEs diagnosed below or at temperature limit (TL) versus above TL\n\nG. FEs according to chemotherapy intensity\n\nH. WD measured core temperature at time of fever detection by ear thermometer\n\nI. FEs reported outside TARs\n\nJ. Quality of life Questionnaire\n\nK. Assessment of the side-effects of the WD\n\nTertiary objective\n\nL. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature\n\nM. Pattern search using data mining'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Age ≥1 month and \\<18 years at time of recruitment\n* Written informed consent from patients and/or parents\n\nExclusion Criteria:\n\n* Neonates \\<1 months\n* Local skin disease prohibiting wearing of the WD\n* Denied written informed consent from patients and/or parents\n* Inclusion of vulnerable participants mandatory as vital signs and FN episodes differ significantly in children and adults'}, 'identificationModule': {'nctId': 'NCT05940766', 'briefTitle': 'Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Swiss 2024 Fever Monitoring'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention "With CFM alerts" arm', 'description': '* 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\n* 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).', 'interventionNames': ['Other: Automated fever alerts']}, {'type': 'NO_INTERVENTION', 'label': 'Control "Without CFM alerts" arm', 'description': '* Routine clinical care as in "With CFM alerts"\n* 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.'}], 'interventions': [{'name': 'Automated fever alerts', 'type': 'OTHER', 'description': 'Fever alerts are automated sent to participants if fever is detected', 'armGroupLabels': ['Intervention "With CFM alerts" arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Bern', 'country': 'Switzerland', 'contacts': [{'name': 'Eva K Brack, MD, MD-PhD', 'role': 'CONTACT', 'email': 'eva.brack@insel.ch'}, {'name': 'Roland Ammann, MD, Prof', 'role': 'CONTACT', 'email': 'info@statconsultammann.ch'}], 'facility': "Childrens' Clinc Bern, Inselspital Bern", 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Eva K Brack, MD, PhD', 'role': 'CONTACT', 'email': 'eva.brack@insel.ch', 'phone': '+41316641943'}, {'name': 'Roland Ammann, MD, Prof.', 'role': 'CONTACT', 'email': 'info@statconsultammann.ch'}], 'overallOfficials': [{'name': 'Eva K Brack, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Childrens' Clinic Bern, Inselspital, Bern"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'End of study', 'ipdSharing': 'YES', 'description': 'Publication in international journal of study protocol and results', 'accessCriteria': 'All study information will be made publically available as long as the patient as signed the informed consent for data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'ETH Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}