Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT07191756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009091', 'term': 'Mucormycosis'}], 'ancestors': [{'id': 'D020096', 'term': 'Zygomycosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000666', 'term': 'Amphotericin B'}, {'id': 'C508735', 'term': 'isavuconazole'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amphotericin B', 'isavuconazole', 'mucormycosis'], 'conditions': ['Mucormycosis']}, 'descriptionModule': {'briefSummary': 'Background:\n\nMucormycosis is a serious but rare fungal infection that requires rapid and effective treatment. The two main antifungal medicines used are amphotericin B and isavuconazole. However, more real-world data is needed to directly compare how well they work and how safe they are for patients.\n\nWhat is the purpose of this study? The main goal of this research study is to compare the effectiveness and safety of amphotericin B versus isavuconazole in treating mucormycosis. Investigators will look at which medicine leads to better survival rates and fewer serious side effects.\n\nHow will the study be done? This is a retrospective study. This means investigators will look back at information that has already been collected. Investigators will analyze data from the medical records of patients who were treated for mucormycosis at three hospitals. Investigators will also review and combine findings from relevant studies published on PubMed.\n\nWhat will the researchers measure?\n\nInvestigators will measure and compare:\n\nHow long patients survived after treatment (survival rates).\n\nWhether the infection was successfully cured or controlled (treatment response).\n\nWhat kinds of side effects (like kidney problems or liver issues) patients experienced with each medicine.\n\nWhat are the possible benefits of this study? This study will not directly benefit the participants whose records are reviewed. However, investigators hope that what investigators learn will help doctors make better treatment decisions for future patients with mucormycosis by providing clearer evidence on the best choice of medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This study will analyze a retrospective cohort of patients with a confirmed diagnosis of mucormycosis who were treated at one of three participating hospitals. The study population will be divided into two groups based on the primary antifungal therapy they received: (1) those who received amphotericin B-based therapy (any formulation), and (2) those who received isavuconazole. Data from eligible patients' medical records will be extracted to form the final study dataset. Additionally, relevant patient data from studies identified via a systematic PubMed literature review may be included to supplement the analysis.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed diagnosis of mucormycosis based on histopathology, culture, or typical radiographic findings in accordance with established guidelines.\n2. Received primary antifungal treatment for mucormycosis with either amphotericin B (any formulation) or isavuconazole for at least 48 hours.\n3. Had at least one follow-up assessment after initiation of antifungal therapy to evaluate treatment response.\n4. Medical records from the participating hospitals are sufficiently complete for data extraction regarding treatment and outcomes.\n\nExclusion Criteria:\n\n* Patients who were not treated with amphotericin B or isavuconazole; and patients who did not have mucormycosis.'}, 'identificationModule': {'nctId': 'NCT07191756', 'acronym': 'AIM', 'briefTitle': 'Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'A Retrospective, Multicenter Cohort Study Comparing the Efficacy and Safety of Amphotericin B Versus Isavuconazole for the Treatment of Mucormycosis: Analysis of Institutional Data and Literature Review', 'orgStudyIdInfo': {'id': '2025-AMB-ISA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amphotericin B Cohort', 'description': 'Patients with a confirmed diagnosis of mucormycosis who received primary treatment with any formulation of amphotericin B (e.g., liposomal amphotericin B, amphotericin B deoxycholate) during the study period. Treatment details, including dosage and duration, were collected from retrospective review of electronic medical records from three participating hospitals.', 'interventionNames': ['Drug: Amphotericin B']}, {'label': 'Isavuconazole Cohort', 'description': 'Patients with a confirmed diagnosis of mucormycosis who received primary treatment with isavuconazole during the study period. Treatment details, including dosage and duration, were collected from retrospective review of electronic medical records from three participating hospitals.', 'interventionNames': ['Drug: Isavuconazole']}], 'interventions': [{'name': 'Amphotericin B', 'type': 'DRUG', 'description': 'This is a retrospective observational study. Patients in this cohort received various formulations of amphotericin B as part of their standard medical care.', 'armGroupLabels': ['Amphotericin B Cohort']}, {'name': 'Isavuconazole', 'type': 'DRUG', 'description': 'This is a retrospective observational study. Patients in this cohort received isavuconazole as part of their standard medical care.', 'armGroupLabels': ['Isavuconazole Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qiu Ye', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Qiu Ye', 'investigatorAffiliation': 'Guangxi Medical University'}}}}