Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00814151
Status:
COMPLETED
Last Update Posted:
2008-12-24
First Post:
2008-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Retention of discrepant blood culture specimens only.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 712}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-23', 'studyFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2008-12-23', 'lastUpdatePostDateStruct': {'date': '2008-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.', 'timeFrame': 'Within 48 hours'}], 'secondaryOutcomes': [{'measure': 'Qualitative feedback on the preliminary MicroPhage test protocol.'}, {'measure': 'Comparative results to market-available S. aureus / MRSA tests for Blood Culture.', 'timeFrame': 'Within 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood culture', 'Staphylococcus aureus', 'Bacteremia', 'MRSA', 'MSSA', 'MicroPhage'], 'conditions': ['Bacteremia', 'Staphylococcal Infection', 'Sepsis', 'Infection']}, 'descriptionModule': {'briefSummary': "In-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform.", 'detailedDescription': 'This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Blood culture positive specimens from three academic medical centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age.\n* Blood culture positive, of ANY of the following bottle types:\n* BD Bactec Standard Aerobic and Anaerobic,\n* BD Bactec Plus Aerobic and Anaerobic,\n* bioMerieux BacT/Alert Standard Aerobic and Anaerobic,\n* bioMerieux BacT/Alert FAN Aerobic and Anaerobic.\n\nExclusion Criteria:\n\n* BD Bactec Lytic, Pediatric, or other bottle types not listed above.\n* bioMerieux Pediatric FAN or other bottle types listed above.\n* Trek bottles.\n* Specimens from patients under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT00814151', 'briefTitle': 'MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPhage, Inc.'}, 'officialTitle': 'Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.', 'orgStudyIdInfo': {'id': 'MP-2008B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MicroPhage', 'description': 'Blood Culture positive specimens available within 24 hours of alarm.', 'interventionNames': ['Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)']}, {'label': 'Standard of Care', 'description': 'Blood Culture positive specimens.'}], 'interventions': [{'name': 'MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)', 'type': 'OTHER', 'description': 'In vitro diagnostic: The MicroPhage "Intervention" was to perform the MicroPhage diagnostic test to detect S. aureus in the blood culture sample and determine MSSA or MRSA status at 4 and 5 hours of test incubation. The "Intervention" results were not made available to the patient or their physician.', 'armGroupLabels': ['MicroPhage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Healthcare Research Institute', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medical Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'J D Smith, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MicroPhage, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPhage, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Scott Conlin', 'oldOrganization': 'MicroPhage, Inc.'}}}}