Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2026-03-10 @ 1:09 AM
Study NCT ID:
NCT06624618
Status:
RECRUITING
Last Update Posted:
2024-10-03
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Lysed whole blood samples from which microbial DNA has been isolated'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis', 'timeFrame': '2 years', 'description': 'The tests will report presence of bacterial DNA by giving a specific bacterial species name.'}, {'measure': 'Patterns of bacterial DNA dynamics over time', 'timeFrame': '2 years', 'description': 'Use of species-specific qPCR primers (either from existing sepsis literature or to be designed) to quantify the DNA load at at least 3 different time points during an infectious episode. Comparison of these loads with infectious parameters used for routine diagnostics and with antibiotic use.'}], 'secondaryOutcomes': [{'measure': 'Distinguishing between the causative pathogen and contamination by a physician evaluation panel, both for the current gold standard (blood cultures) and the results of new microbiological tests for detecting sepsis pathogens', 'timeFrame': '2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Culture-free', 'Whole blood', 'Molecular diagnosis', 'Sepsis', 'Bloodstream infection', 'Bacterial DNA'], 'conditions': ['Sepsis', 'Bloodstream Infection']}, 'descriptionModule': {'briefSummary': 'Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at the Intensive Care Unit (ICU) of Maastricht University Medical Center (MUMC) are eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.\n\nExclusion Criteria:\n\n-N/A'}, 'identificationModule': {'nctId': 'NCT06624618', 'acronym': 'RADOS', 'briefTitle': 'Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Rapid Molecular Detection of Sepsis in Whole Blood', 'orgStudyIdInfo': {'id': '2023-0344'}}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Anna Wijen, Msc', 'role': 'CONTACT', 'email': 'anna.wijen@maastrichtuniversity.nl', 'phone': '0031626882868'}, {'name': 'Paul Savelkoul, Prof. Dr.', 'role': 'CONTACT', 'email': 'paul.savelkoul@mumc.nl', 'phone': '0031433876644'}, {'name': 'Paul Savelkoul, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Anna Wijen, Msc', 'role': 'CONTACT'}, {'name': 'Christian von Wintersdorff, Dr.', 'role': 'CONTACT'}, {'name': 'Rob Driessen, Dr.', 'role': 'CONTACT'}, {'name': 'Dennis Bergmans, Dr.', 'role': 'CONTACT'}], 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Anna Wijen, Msc.', 'role': 'CONTACT', 'email': 'anna.wijen@maastrichtuniversity.nl', 'phone': '+31 626882868'}, {'name': 'Paul Savelkoul, Prof. Dr.', 'role': 'CONTACT', 'email': 'paul.savelkoul@mumc.nl', 'phone': '+31 433876610'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Holland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}