Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-31 @ 6:36 AM
Study NCT ID:
NCT01525095
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2012-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058387', 'term': 'Candidemia'}, {'id': 'C536972', 'term': 'Torulopsis'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D016469', 'term': 'Fungemia'}, {'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': 'Whole Blood specimens, in addition to bacterial and fungal species isolates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-06', 'studyFirstSubmitDate': '2012-01-25', 'studyFirstSubmitQcDate': '2012-02-01', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Candida Positive patients', 'timeFrame': '3-5 days post blood culture', 'description': 'Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal'}], 'secondaryOutcomes': [{'measure': 'Number of Candida Negative Patients', 'timeFrame': '3-5 days post blood culture', 'description': 'Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Candida', 'Diagnostic Assay', 'Blood culture', 'Sepsis', 'T2 Magnetic Relaxation'], 'conditions': ['Candidemia']}, 'referencesModule': {'references': [{'pmid': '29438475', 'type': 'DERIVED', 'citation': 'Clancy CJ, Pappas PG, Vazquez J, Judson MA, Kontoyiannis DP, Thompson GR 3rd, Garey KW, Reboli A, Greenberg RN, Apewokin S, Lyon GM 3rd, Ostrosky-Zeichner L, Wu AHB, Tobin E, Nguyen MH, Caliendo AM. Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel. Clin Infect Dis. 2018 May 17;66(11):1678-1686. doi: 10.1093/cid/cix1095.'}, {'pmid': '23315320', 'type': 'DERIVED', 'citation': 'Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who have undergone a diagnostic blood culture.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.\n2. For Group A,\n\n * Males and females 18 - 95 years of age.\n * Subject is confirmed to have fungemia as evidenced by a positive diagnostic blood culture and subsequent species identification.\n3. For Group B,\n\n * Males and females 18 - 95 years of age.\n * Subject is hospitalized with a medical problem other than fungemia, or is being treated as an outpatient for some non-infection-related condition, and\n * Subject is confirmed to not have fungemia as evidenced by diagnostic blood culture and subsequent species identification.\n\nExclusion Criteria:\n\n1. Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.\n2. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study."}, 'identificationModule': {'nctId': 'NCT01525095', 'acronym': 'DIRECT', 'briefTitle': 'Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'T2 Biosystems'}, 'officialTitle': 'Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)', 'orgStudyIdInfo': {'id': 'PRO-00030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Candida Positive Patients', 'description': 'Symptomatic adult patients, confirmed via concordant diagnostic blood culture and species identification and subsequent second blood culture results and species identification that are Candida positive'}, {'label': 'Candida Negative Patients', 'description': 'Hospitalized adult patients, confirmed via concordant diagnostic blood culture with subsequent species identification and subsequent second blood culture with subsequent species identification that are Candida negative'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '40536-0298', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston College of Pharmacy', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Peter Pappas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'T2 Biosystems', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}