Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-27 @ 8:09 PM
Study NCT ID:
NCT06907992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058387', 'term': 'Candidemia'}], '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': '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': 'whole blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication of candida from the blood at day 7 or day 14', 'timeFrame': '14 Days', 'description': 'Blood culture monitoring at day 7 and day 14'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['candidemia', 'uncomplicated candidemia', 'antifungal therapy', 'echinocandin', 'caspofungin', 'micafungin', 'rezafungin', 'anidulafungin'], 'conditions': ['Candidemia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from:\n\nA. Inpatient settings based on positive blood cultures for candidemia. B. Daily review of microbiology labs C. Referrals from investigators, ICUs and hospital unit personnel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.\n3. Received \\< 5 days of prior antifungal therapy\n4. Informed Consent for randomization\n5. Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.\n\nExclusion Criteria:\n\n1. Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).\n2. Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)\n3. Abnormal LFTs \\> 10-fold\n4. Greater than 5 days of prior antifungal therapy\n5. Endovascular devices that cannot be removed.\n6. Immunocompromised patients (AIDS/HIV; solid organ transplant, bone marrow transplant patients, oncology patients receiving chemotherapy, neutropenic patients (ANC of \\< 1,500 cells/L\n7. Neutropenic at time of consent (what does this mean)\n8. Break-through candidemia (people with prior candidemia who relapsed) after treatment with antifungal therapy)\n9. Unable to provide informed consent from either the patient or legally authorized authority (LAR)\n10. Expected mortality within 96 hours'}, 'identificationModule': {'nctId': 'NCT06907992', 'acronym': 'SCAT', 'briefTitle': 'A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Short-Course Antifungal Therapy vs Standard of Care (14 Day Therapy) for Uncomplicated Candidemia (SCAT)', 'orgStudyIdInfo': {'id': 'MSG 23'}, 'secondaryIdInfos': [{'id': 'U01CK000692', 'link': 'https://reporter.nih.gov/quickSearch/U01CK000692', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '7 Days', 'description': 'Study participants randomized to the 7 Day group will receive the short-course antifungal therapy for 7 days.', 'interventionNames': ['Drug: Antifungal treatment']}, {'label': '14 Days', 'description': 'Study participants randomized to the 14 Day group will receive the standard of care antifungal therapy for 14 days.', 'interventionNames': ['Drug: Antifungal treatment']}], 'interventions': [{'name': 'Antifungal treatment', 'type': 'DRUG', 'description': 'Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)', 'armGroupLabels': ['14 Days', '7 Days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Aprile Osborn, MSN', 'role': 'CONTACT', 'email': 'aosborn@augusta.edu', 'phone': '706-721-0309'}], 'overallOfficials': [{'name': 'Jose Vazquez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose Vazquez', 'investigatorAffiliation': 'Augusta University'}}}}