Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-27 @ 7:43 PM
Study NCT ID:
NCT04652050
Status:
WITHDRAWN
Last Update Posted:
2023-04-24
First Post:
2020-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "excess biological samples collected as part of the patient's clinical care will be obtained if available for further testing/analysis for amounts of Tolsura"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Patients are not interested to participate', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK Sampling-measure amount of drug in system', 'timeFrame': 'one day PK sampling', 'description': 'blood samples around a dosing of Tolsura to determine maximum plasma concentration'}], 'secondaryOutcomes': [{'measure': 'rates of infection post treatment with Tolsura', 'timeFrame': '6 months', 'description': 'follow lung transplant recipients till end of Tolsura treatment and determine rates of infection for as well as type of infections'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung transplant'], 'conditions': ['Lung Transplant Infection']}, 'descriptionModule': {'briefSummary': 'This is a single-center, observational study of Tolsura PK sampling in lung transplant recipients', 'detailedDescription': 'Patients who are receiving Tolsura as part of their clinical care will be asked to enroll and EMR data and excess biological samples will be collected'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'lung transplants on Tolsura that meet entry criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* hospitalized at UPMC\n* placed on Tolsura prophylactically by clinical team\n* patients who have had or will have a lung transplant.\n\nExclusion Criteria:\n\n* redo lung transplant\n* recipient with dual liver-lung transplant\n* patients with previous history of SOT\n* including other organ transplantation\n* patients with known pre-transplant colonization with moulds resistant to azoles\n* patients with intra-transplant positive cultures for moulds in either transplant recipient or his/her donor\n* patients with a history of hypersensitivity reaction to an azole agent\n* patients who are kept NPO (nothing by mouth, including meds)\n* recipients or donor with HepC PCR positive'}, 'identificationModule': {'nctId': 'NCT04652050', 'acronym': 'Tolsura', 'briefTitle': 'Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation', 'orgStudyIdInfo': {'id': 'STUDY20080119'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lung transplants', 'description': 'Lung transplants on Tolsura for infection', 'interventionNames': ['Drug: Tolsura']}], 'interventions': [{'name': 'Tolsura', 'type': 'DRUG', 'description': 'Patients fulfilling the inclusion criteria (see above) and placed on Tolsura for prophylaxis, and signed informed consent to participate in this study will be part of the study.', 'armGroupLabels': ['lung transplants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Hong Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPMC and PITT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "If data is shared all data provided de identified using alpha/numeric codes and MTA and/or DUA's will be in put in place prior to sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Nguyen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hong Nguyen', 'investigatorAffiliation': 'University of Pittsburgh'}}}}