Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-12 @ 6:11 AM
Study NCT ID:
NCT06495905
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-11
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C068538', 'term': 'liposomal amphotericin B'}, {'id': 'C101425', 'term': 'posaconazole'}, {'id': 'C508735', 'term': 'isavuconazole'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, Intervention, observational, Propensity Matching Analysis study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of complete or partial response at 4 weeks', 'timeFrame': '4 weeks', 'description': '* Complete response: Resolution of all clinical signs and symptoms and more than 90% of lesions visible on radiology\n* Partial response: Clinical improvement and \\>50% improvement in findings on radiology'}], 'secondaryOutcomes': [{'measure': 'the rate of complete or partial response at 12 weeks', 'timeFrame': '12 weeks', 'description': '* Complete response: Resolution of all clinical signs and symptoms and more than 90% of lesions visible on radiology\n* Partial response: Clinical improvement and \\>50% improvement in findings on radiology'}, {'measure': 'Survival rate at 6 months', 'timeFrame': '6 months', 'description': 'estimates using all-cause mortality at 12 months'}, {'measure': 'the incidence of adverse reactions related to this comprehensive treatment at 4 weeks', 'timeFrame': '4 weeks', 'description': 'The adverse reactions were assessed based on the Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary mucormycosis', 'bronchoscopy', 'treatment'], 'conditions': ['Pulmonary Mucormycosis']}, 'referencesModule': {'references': [{'pmid': '40830172', 'type': 'DERIVED', 'citation': 'Luo Q, He X, Xu J, Li L, Zhao L, Mu X. Reduced serum iron levels predict poor prognosis in pulmonary mucormycosis patients: a prospective, case-control study. Sci Rep. 2025 Aug 19;15(1):30395. doi: 10.1038/s41598-025-15186-3.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the effectiveness and safety of transbronchoscopic local precision infusion of amphotericin B + transoral nebulized inhalation of amphotericin B + transbronchoscopic interventional debridement + liposomal amphotericin B + posaconazole or Isavuconazole multimodal treatment of pulmonary mucormycosis', 'detailedDescription': 'Key rationale for the treatment of mucormycosis is early surgical intervention, including local debridement and removal of infected tissues or organs if possible. Systemic antifungal therapy is also necessary for mucormycosis, including amphotericin B liposomes and deoxycholates, Isavuconazole, posaconazole, and so on. Antifungal drug therapy has a mortality rate of up to 40%, which can be reduced to 23% when combined with surgical treatment. However, some patients who are unable to tolerate surgical procedures on the chest when in bad condition, especially patients with hematological malignancies undergoing hematopoietic stem cell transplantation, are susceptible to multiple mucormycosis of the lungs, and the mortality rate of untreated systemically disseminated mucormycosis infections is high at 80%. Isavuconazole, so we aim to explore the multimodal treatment of liposomal amphotericin B + posaconazole or esaconazole + transbronchoscopic localized precise instillation of amphotericin B + oral nebulized inhalation of amphotericin B + transbronchoscopic interventional debridement to alleviate the pulmonary mucormycosis in chest imaging and reduce the mortality rate of patients with mucormycosis infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects suspected of pulmonary mucormycosis by clinical radiology will be enrolled in the study if the pathologic or microbiological diagnosis of mucormycosis (smear showing sterile mycelium, culture or molecular evidence of mucormycosis) is confirmed.\n* Cases of diffuse mucormycosis will only be included if lung infection is confirmed pathologically or microbiologically by respiratory secretions or biopsy samples.\n* Ability to tolerate bronchoscopy.\n\nExclusion Criteria:\n\n* Pregnant and breastfeeding female patients\n* Age \\<18 years\n* Patients with HIV infection\n* Contraindications to bronchoscopy (including platelet count \\< 100 x 109/L, active hemoptysis, severe respiratory or heart failure, severe arrhythmia, unstable angina or hypertension, severe pneumothorax or mediastinal emphysema, patients with acute myocardial infarction, cerebral infarction, and cerebral hemorrhage within 3 months\n* Patients unable to tolerate bronchoscopy'}, 'identificationModule': {'nctId': 'NCT06495905', 'briefTitle': 'Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'Evaluation of the Effectiveness and Safety of Transbronchoscopic Infusion of Amphotericin B + Inhalation of Amphotericin B + Transbronchoscopic Debridement + Systematic Antifungal Multimodal Treatment of Pulmonary Mucormycosis', 'orgStudyIdInfo': {'id': 'ST&BITPM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal Treatment', 'description': '1. combination drug therapy：liposomal amphotericin B + posaconazole or Isavuconazole：3-5mg/kg/day+ Posaconazole 300 mg once daily; target blood trough concentration is \\>1ug/mL; if posaconazole is unavailable, Isavuconazole 200 mg once daily may be an alternative.\n2. transbronchoscopic local precision infusion of amphotericin B: Maximum dose not more than 30mg per session\n3. transoral nebulized inhalation of amphotericin B：amphotericin B 10mg + 5ml of sterilized water for injection, inhalation 2/day.\n\n4)transbronchoscopic interventional debridement', 'interventionNames': ['Procedure: transbronchoscopic interventional debridement']}], 'interventions': [{'name': 'transbronchoscopic interventional debridement', 'type': 'PROCEDURE', 'otherNames': ['transbronchoscopic local precision infusion of amphotericin B', 'transoral nebulized inhalation of amphotericin B', 'liposomal amphotericin B + posaconazole or Isavuconazole'], 'description': '1. combination drug therapy：liposomal amphotericin B + posaconazole or Isavuconazole：3-5mg/kg/day+ Posaconazole 300 mg once daily; target blood trough concentration is \\>1ug/mL; if posaconazole is unavailable, Isavuconazole 200 mg once daily may be an alternative.\n2. transbronchoscopic local precision infusion of amphotericin B: Maximum dose not more than 30mg per session\n3. transoral nebulized inhalation of amphotericin B：amphotericin B 10mg + 5ml of sterilized water for injection, inhalation 2/day.\n\n4)transbronchoscopic interventional debridement', 'armGroupLabels': ['Multimodal Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing TsingHua ChangGung hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Manting Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tsinghua University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}