Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-28 @ 6:34 PM
Study NCT ID:
NCT02719769
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2016-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D016469', 'term': 'Fungemia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'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'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Frozen positive blood cultures and bacterial and yeast isolates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4009}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison Study - ID Performance', 'timeFrame': 'Approximately 9 months (including pre-clinical phase)', 'description': 'Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target'}], 'secondaryOutcomes': [{'measure': 'Comparison Study - AST Performance', 'timeFrame': 'Approximately 9 months (including pre-clinical phase)', 'description': 'Essential and Categorical Agreement with CLSI Frozen Reference Method (BMD) by Antimicrobial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Positive Blood Culture'], 'conditions': ['Bacteremia', 'Fungemia']}, 'descriptionModule': {'briefSummary': 'The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \\& Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical setting. The data from this study will be used to support the 510(k) submission for FDA clearance and global registrations of the device intended for in vitro diagnostic use.', 'detailedDescription': 'The clinical study entitled "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \\& Antimicrobial Susceptibility Testing" is designed to demonstrate the clinical performance of the Accelerate ID/AST System for positive blood culture identification (ID) and antimicrobial susceptibility testing (AST) in a clinical setting compared to reference results. Approximately 3,000 positive blood culture samples (across all Clinical Sites) will be tested on the investigational device and reference methods. Up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. Quality Control testing will be performed each day of testing. The study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. Positive blood culture samples must be tested on the Accelerate ID/AST System within 8 hours of positivity by the blood culture monitoring system. Testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* De-identified positive blood culture specimens (6 mL aliquot)\n* Seeded blood culture specimens (stock) from archived bacterial and yeast isolates\n\nExclusion Criteria:\n\n* Sample volume available \\< 6 mL\n* Positive Blood Culture sample \\> 8 hours post-positivity\n* Sample from patient previously enrolled\n* Sample from blood culture media that contain charcoal e.g., BACTAlert FA, FN bottles\n* Samples from Mycobacterial-type blood culture media e.g., BACTEC Myco/F Lytic, BacT/ALERT MP Bottle, VersaTREK Myco'}, 'identificationModule': {'nctId': 'NCT02719769', 'briefTitle': 'Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accelerate Diagnostics, Inc.'}, 'officialTitle': 'Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing', 'orgStudyIdInfo': {'id': 'CP000004'}, 'secondaryIdInfos': [{'id': 'CP00002', 'type': 'OTHER', 'domain': 'Accelerate Diagnostics'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health- Laboratory Sciences of Arizona', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85714', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Accelerate Diagnostics Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90046', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32909-2211', 'city': 'Palm Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'MRI Global', 'geoPoint': {'lat': 28.03446, 'lon': -80.58866}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '52242-1396', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '13088', 'city': 'Liverpool', 'state': 'New York', 'country': 'United States', 'facility': 'Lab Alliance of Central New York LLC', 'geoPoint': {'lat': 43.10646, 'lon': -76.2177}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Clinic', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '75067', 'city': 'Lewisville', 'state': 'Texas', 'country': 'United States', 'facility': 'med fusion LLC', 'geoPoint': {'lat': 33.04623, 'lon': -96.99417}}, {'zip': '53276', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Constance Bridges, B.S., MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Accelerate Diagnostics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accelerate Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}