Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT04821661
Status:
UNKNOWN
Last Update Posted:
2023-08-08
First Post:
2021-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T2 and SeptiCyte RAPID Duration Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'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': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay', 'timeFrame': 'Days 1-4', 'description': 'The T2 system is a new diagnostic detection method utilizing miniaturized magnetic resonance technology. The T2 system has been shown to quickly and accurately identify molecular targets within patient samples without the need for purification or extraction of target molecules from the sample. It does not require bacterial culture and can detect organisms as low as 1 CFU/mL in whole blood. The study will compare the duration of detectable pathogens in the bloodstream as measured by the T2 with the duration of bloodstream infection according to conventional cultures'}, {'measure': 'Persistent infection defined as metastatic infection and lack of source control', 'timeFrame': 'Days 1-4', 'description': 'The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and the presence of persistent infection'}], 'secondaryOutcomes': [{'measure': 'Short-term clinical outcome (SOFA success)', 'timeFrame': 'Days 1-7', 'description': 'The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and short-term clinical outcome. A "successful short-term outcome" or "SOFA success" is defined as survival for the first 7 days from BSI onset with a stable or decreased Sequential Organ Failure Assessment (SOFA) score (for ICU patients) or modified SOFA score (for non-ICU patients), defined as follows: if the baseline SOFA/mSOFA \\>=3, a decrease of at least 30% in that score, if the baseline SOFA/mSOFA \\<3, a stable or decreased SOFA/mSOFA score. Patients discharged before day 7 will be assumed to have improved SOFA scores. The lack of "SOFA success" will be defined "SOFA failure".'}, {'measure': 'Long-term clinical outcome', 'timeFrame': '6-months from the index BSI', 'description': 'The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and long-term clinical outcomes. A "successful long-term outcome" is defined as survival for the first 6 months from the BSI onset and maintenance of the baseline functional performance status defined by the functional bloodstream infection score (FBIS) score 7 days prior to the BSI onset.'}, {'measure': 'Persistent infection', 'timeFrame': 'Day 1-4', 'description': 'SeptiCyte is a host-response assay able to differentiate infectious from sterile inflammation by providing a score (SeptiScore) from 1-15. It is approved for the diagnosis of sepsis in ICU patients. Whether SeptiScore may have a role in diagnosing the persistence of the infection in patients with proven BSI is unknown. The study will explore the performance of SeptiScore in diagnosing persistent infection including persistent BSI and metastatic infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bacteraemia', 'Gram-negative Bacteremia', 'Bacterial Infections', 'T2 magnetic resonance assay', 'SeptiCyte RAPID'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'Infection with bacteria and other germs in the blood can be deadly. How long germs stay in the blood is important for two reasons. The first is that if they stay in the blood for many days it is a sign that antibiotics may need to be changed. The second is that if they stay in the blood for only a short time it may give doctors confidence to switch to tablets and consider early discharge from hospital. This study is evaluating the diagnostic and prognostic performance of two novel technologies when used to measure the duration of the bloodstream infection.', 'detailedDescription': 'Bloodstream infection is highly significant and is associated with mortality rates of between 10 and 25%.\n\nFor some infection types (for example, Staphylococcus aureus) a longer duration of bacteria being present in the blood is linked to higher mortality. With traditional microbiologic techniques, bloodstream infection with gram-negative bacteria is usually quite brief. However, new culture independent bacteraemia detection systems (such as T2 magnetic resonance assay) are more sensitive than traditional blood culture systems and may show that gram-negative bacteraemia is more prolonged in some patients than has previously been thought. This observational study will investigate the correlation between the duration of bloodstream infection by mean of traditional blood culture techniques with:\n\n1. Duration of the bloodstream infection by mean of the T2 magnetic resonance assay, a new culture independent bacteraemia detection system.\n2. Persistence of inflammation as measured by the SeptiCyte RAPID test, a host response assay able to differentiate infectious from sterile inflammation.\n\nThe study will also correlate each measure of the duration of bacteraemia with microbiological and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients at the Royal Brisbane and Women's Hospital, Caboolture Hospital and Redcliffe Hospital who have bacteria or yeast in the blood identified by the MALDI-TOF MS and Gram stain respectively", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have proven bloodstream infection with any T2-on panel pathogen (Enterococcus faecium, S. aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli and Candida spp.)\n\nExclusion Criteria:\n\n* Palliative care approach\n* Failure to give written informed consent (by patient or their legal representative)\n* Polymicrobial index blood culture'}, 'identificationModule': {'nctId': 'NCT04821661', 'briefTitle': 'T2 and SeptiCyte RAPID Duration Project', 'organization': {'class': 'OTHER', 'fullName': 'The University of Queensland'}, 'officialTitle': 'Duration of Bloodstream Infection as Measured by Conventional Cultures Compared With Novel Culture Independent Systems and Persistence of Biomarkers Associated With Severe Infection', 'orgStudyIdInfo': {'id': 'HREC/2021/QRBW/70126'}}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': "Kevin O'Callaghan", 'role': 'CONTACT'}], 'facility': 'Caboolture Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Brisbane', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nastaran Rafiei', 'role': 'CONTACT'}], 'facility': 'Redcliffe Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Hugh Wright', 'role': 'CONTACT'}], 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'centralContacts': [{'name': 'Tiffany Harris-Brown', 'role': 'CONTACT', 'email': 't.harrisbrown@uq.edu.au', 'phone': '+61 7 3346 6072'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Queensland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Metro North Hospital and Health Service', 'class': 'UNKNOWN'}, {'name': 'Pathology Queensland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor David L. Paterson', 'investigatorAffiliation': 'The University of Queensland'}}}}