Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06354205
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation', 'timeFrame': 'One year', 'description': 'the correlation between serum Procalcitonin (PCT) levels and salivary PCT levels'}], 'secondaryOutcomes': [{'measure': 'Diagnose', 'timeFrame': 'One year', 'description': 'Diagnostic value of saliva PCT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['procalcitonin', 'saliva', 'children', 'infection'], 'conditions': ['Bacterial Infections', 'Children, Only', 'Procalcitonin', 'Saliva']}, 'descriptionModule': {'briefSummary': 'Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.\n\nThe aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being under one year of age\n* Having serum Procalcitonin (PCT) requested due to suspicion of systemic infection\n\nExclusion Criteria:\n\n* Being over one year of age\n* Having a chronic illness that could cause elevation in inflammatory biomarkers\n* Taking any medication (such as antibiotics, immunomodulatory, or immunosuppressive drugs, etc.) that could affect inflammatory biomarkers\n* Diagnosis of gingivostomatitis'}, 'identificationModule': {'nctId': 'NCT06354205', 'briefTitle': 'Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels in Infants Under 1 Year of Age Suspected of Systemic Bacterial Infection', 'orgStudyIdInfo': {'id': '24-3.1T/98'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients selection', 'description': 'Children under 1 year of age will be recruited for saliva and blood sample collection in the study', 'interventionNames': ['Diagnostic Test: Sliva Procalcitonin']}], 'interventions': [{'name': 'Sliva Procalcitonin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sliva Procalcitonin vs Blood procalcitonin', 'armGroupLabels': ['Patients selection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Caner Turan', 'role': 'CONTACT'}], 'facility': 'Ege University School of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Caner Turan, PhD', 'role': 'CONTACT', 'email': 'drcanerturan@gmail.com', 'phone': '+902323901510'}, {'name': 'Sercan Cinarli', 'role': 'CONTACT', 'email': 'sercancinarli4@gmail.com', 'phone': '+902323901001'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Caner Turan', 'investigatorFullName': 'Caner Turan', 'investigatorAffiliation': 'Ege University'}}}}