Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-25 @ 2:41 PM
Study NCT ID:
NCT07261150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006660', 'term': 'Histoplasmosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101425', 'term': 'posaconazole'}, {'id': 'D014944', 'term': 'World Health Organization'}], 'ancestors': [{'id': 'D014480', 'term': 'United Nations'}, {'id': 'D007390', 'term': 'International Agencies'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 664}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality at 2 weeks', 'timeFrame': 'Week 2'}, {'measure': 'Mortality at 26 weeks', 'timeFrame': 'Week 26'}, {'measure': 'SAE-free survival between 26 and 52 weeks from induction therapy among those who survived 26 weeks', 'timeFrame': 'Week 52'}], 'secondaryOutcomes': [{'measure': 'Aim 1: Hierarchical composite end point', 'timeFrame': 'Week 56', 'description': 'Consisting of the following in a hierarchical order:\n\n5: Death within 10 weeks or lost to follow up in the first 1 week 4: Serious Adverse event within 10 weeks 3: Grade 4 laboratory abnormality at week two visit or discontinuation of medication due to intolerance during the first 10 weeks 2: Grade 3 laboratory abnormality at week two visit\n\n1: Alive at the end of the study period without one of the above events'}, {'measure': 'Aim 2: Hierarchical composite end point', 'timeFrame': 'Week 56', 'description': 'Consisting of the following in a hierarchical order:\n\n5: Death within the study period 4: Serious Adverse event within 26 weeks 3: Grade 4 laboratory abnormality through week 26 or discontinuation of medication due to intolerance during the first 26 weeks 2: Grade 3 laboratory abnormality through week 26 or or lost to follow up after the first week\n\n1: Alive at the end of the study period without one of the above events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Histoplasmosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is threefold:\n\n1. Assess the safety and efficacy of a single high-dose intravenous (LAmB 10mg/kg) compared to the SOC daily dosing (3mg/kg) of the same medication for induction therapy in moderate to severe histoplasmosis.\n2. Assess the safety and efficacy of oral posaconazole 300mg delayed-release tablets three times daily for two days then once daily for consolidation therapy compared to SOC oral itraconazole 200 mg capsules three times daily for three days then twice daily in moderate to severe histoplasmosis\n3. Assess the safety and efficacy of 6 months of consolidation therapy compared to the SOC 12 months of consolidation therapy in persons with HIV on appropriate antiretroviral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Hospitalized with suspected histoplasmosis b\n* Diagnosis of confirmed or probable histoplasmosis (via positive Histoplasma antigen test, culture, histopathology or microscopy)\n* Provision of Informed Consent by participant or surrogate c\n\nExclusion Criteria:\n\n* Previous diagnosis of histoplasmosis\n* Pregnant persons (all persons who could potentially be pregnant will have a pregnancy test prior to enrollment, and if negative, must agree to contraception for the duration of the study)\n* Breastfeeding and unable to stop for the duration of the study\n* Renal impairment (serum creatinine or blood urea nitrogen (BUN) \\>2.0x upper limit of normal)\n* Allergy or contraindication to a study medicine\n* More than one dose of an amphotericin product in the prior 7 days\n* Suspected central nervous system involvement of histoplasmosis\n* Likely to die in the next 48 hours in the judgment of the investigator\n* Unlikely to follow up for the duration of the study in the judgement of the investigator\n* Significant drug-drug interaction with itraconazole or posaconazole (such as rifampin in persons with TB)\n* Current diagnosis of cryptococcosis or leishmaniasis\n* QTc interval consistently \\>450 milliseconds\n* Prisoners\n* Unable to take oral medications'}, 'identificationModule': {'nctId': 'NCT07261150', 'briefTitle': 'Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)', 'orgStudyIdInfo': {'id': 'IDIM-2025-33491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Induction Therapy - Experimental', 'description': 'Single high-dose (10mgkg) of LAmB B', 'interventionNames': ['Drug: LAmB B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Induction Therapy - Standard of Care', 'description': 'SOC daily standard dose (3mg/kg) LAmB', 'interventionNames': ['Drug: World Health Organization (WHO)-recommended SOC']}, {'type': 'EXPERIMENTAL', 'label': 'Consolidation Therapy - Experimental', 'description': 'posaconazole', 'interventionNames': ['Drug: Posaconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Consolidation Therapy - Standard of Care', 'description': 'SOC itraconazole', 'interventionNames': ['Drug: WHO-recommended SOC Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Total Consolidation - Experimental', 'description': '6 months total (e.g., 0 additional months) of itraconazole or posaconazole based on assignment from Aim 2.', 'interventionNames': ['Drug: Posaconazole', 'Drug: WHO-recommended SOC Itraconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total Consolidation - Standard of Care', 'description': '12 months total (e.g., 6 additional months) of itraconazole or posaconazole based on assignment from Aim 2', 'interventionNames': ['Drug: Posaconazole', 'Drug: WHO-recommended SOC Itraconazole']}], 'interventions': [{'name': 'LAmB B', 'type': 'DRUG', 'description': 'intravenous liposomal amphotericin B (10mg/kg)', 'armGroupLabels': ['Induction Therapy - Experimental']}, {'name': 'Posaconazole', 'type': 'DRUG', 'description': 'Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily', 'armGroupLabels': ['Consolidation Therapy - Experimental', 'Total Consolidation - Experimental', 'Total Consolidation - Standard of Care']}, {'name': 'World Health Organization (WHO)-recommended SOC', 'type': 'DRUG', 'description': 'daily intravenous liposomal amphotericin B 3mg/kg, for 2 weeks or at least 7 days if felt stable for discharge per the clinician', 'armGroupLabels': ['Induction Therapy - Standard of Care']}, {'name': 'WHO-recommended SOC Itraconazole', 'type': 'DRUG', 'description': '200mg capsules three times daily x 3 days then twice daily', 'armGroupLabels': ['Consolidation Therapy - Standard of Care', 'Total Consolidation - Experimental', 'Total Consolidation - Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Nathan Bahr', 'role': 'CONTACT', 'email': 'bahrx026@umn.edu'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'contacts': [{'name': 'Alessandro Pasqualotto', 'role': 'CONTACT', 'email': 'pasqualotto@santacasa.org.br'}], 'facility': 'Universidade Federal de Ciências da Saúde de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Nathan Bahr, MD', 'role': 'CONTACT', 'email': 'bahrx026@umn.edu', 'phone': '612-624-9996'}], 'overallOfficials': [{'name': 'Nathan Bahr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}