Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05116059
Status:
UNKNOWN
Last Update Posted:
2022-10-21
First Post:
2021-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of ABCD in the Treatment of IFD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'therapeutic response rate', 'timeFrame': 'within one week of the last administration of ABCD', 'description': 'Patients with hematological tumors are evaluated for efficacy according to the diagnostic criteria and treatment principles for invasive mycoses in patients with hematological diseases/malignant tumors (the sixth revised edition). Efficacy assessment criteria for patients with non-hematological tumors are defined as complete and partial response as effective, and stable, progress and death as ineffective.'}, {'measure': 'Infusion reaction, renal toxicity, hypokalemia, liver function and other adverse events [Safety and Tolerability]', 'timeFrame': 'from the date of start medication until the date of last dose of ABCD. If the adverse reaction has not ended after 2 weeks, clinicians are advised to follow up until the adverse event has recovered or stabilized (Assessed up to 1 week).', 'description': 'The incidence, start and end times, and severity of adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amphotericin B Colloidal Dispersion', 'Invasive fungal disease'], 'conditions': ['Invasive Fungal Disease']}, 'referencesModule': {'references': [{'pmid': '40384797', 'type': 'DERIVED', 'citation': 'Zhang L, Zhang Q, Ma W, Chu ZB, Xu L, Xing H, Wang J, Lin J, Liu Z. Efficacy and Safety of Amphotericin B Colloidal Dispersion for Patients with Invasive Fungal Disease and Febrile Neutropenia: A Registry-Based, Multicenter, Retrospective, Real-World Study. Infect Drug Resist. 2025 May 13;18:2475-2487. doi: 10.2147/IDR.S494985. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'In order to better guide clinical medication, verify the efficacy and safety of ABCD in the treatment of various invasive fungal disease, the investigators have designed a multi-center, retrospective registration study. Diagnosis and treatment data for patients with different types of invasive fungal disease in clinical actual environment was collapsed by a database for collaborative exchange on antifungal research.', 'detailedDescription': 'This study is a retrospective, non-interventional, and observational study. The clinical data of the patient during hospitalization shall be collected at least 2 weeks after the end of the ABCD drug, including basic data of the patient, laboratory data and clinical treatment, mainly covering antifungal medications, such as pretreatment measures, drug dosage and dispensing method, route of administration, duration of administration, efficacy and adverse reactions, etc. If adverse events related to ABCD have not ended after 2 weeks, investigators are advised to follow up until the adverse events recover or stabilize. It is hoped that the basic situation of Chinese invasive fungal patients is described, and ABCD is evaluated in the treatment of invasive fungal patients. In addition, prognostic factors can be analyzed to optimize clinical medication regimen and provide basis support for clinical medication of ABCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with invasive fungal disease and accepted of ABCD', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients with possible/probable/proven invasive fungal disease according to EORTC-MSG diagnostic criteria.\n3. Patients received ABCD alone or in combination with other antifungals on either empirical, diagnosis-driven or targeted therapy.\n4. There is no limit to the patient's previous treatment plan.\n\nExclusion Criteria:\n\n1. Patients judged by clinicians to be unsuitable for this study.\n2. Patients with incomplete data or other factors affecting the judgment of efficacy and safety."}, 'identificationModule': {'nctId': 'NCT05116059', 'briefTitle': 'To Evaluate the Efficacy and Safety of ABCD in the Treatment of IFD', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'To Evaluate the Efficacy and Safety of Amphotericin B Colloidal Dispersion (ABCD) in the Treatment of Invasive Fungal Disease: a Multicenter, Retrospective, Observational, Non-interventional Registration Study', 'orgStudyIdInfo': {'id': 'CSPC-ABCD-K02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amphotericin B colloidal dispersion（ABCD）', 'type': 'DRUG', 'description': 'The dosage and course of ABCD were determined by clinicians, and this study was registered according to clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengyin Liu, PhD', 'role': 'CONTACT', 'email': 'zhengyinl@hotmail.com', 'phone': '010-69156114'}, {'name': 'Zhengyin Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'zhengyin Liu, PhD', 'role': 'CONTACT', 'email': 'zhengyinl@hotmail.com', 'phone': '010-69156114'}], 'overallOfficials': [{'name': 'zhengyin Liu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}