Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT02568358
Status:
UNKNOWN
Last Update Posted:
2015-10-05
First Post:
2015-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bronchoalveolar lavage'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-02', 'studyFirstSubmitDate': '2015-10-02', 'studyFirstSubmitQcDate': '2015-10-02', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection", 'timeFrame': '6 month', 'description': "Cohen's kappa measures the agreement between methods and the final clinical diagnosis. Both methods (DNA-based testing and standard cultures) will result in isolation of a non-viral pathogen or no isolation of a pathogen. A final clinical diagnosis will classify patients clinically in two categories as non-viral lower respiratory tract infection or no non-viral lower respiratory tract infection usually made 48-72 hours made after sampling. Cohen's kappa will be compared between the two methods."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lower Respiratory Tract and Lung Infections']}, 'descriptionModule': {'briefSummary': 'Lung transplantation (LTx) , DNA-based testing.\n\nPerformance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing.\n\nExperimental intervention: DNA-based testing of BAL fluid.', 'detailedDescription': "Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Lung transplant recipients with suspected non-viral lower respiratory tract infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients after lung transplantation (single, double or combined)\n* suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of\n* new onset of malaise\n* new or progressive pulmonary infiltrate\n* hypoxemia (SpO2/SaO2 \\<92% or need for oxygen)\n* temperature of 38 o C or above within 7 days\n* purulent (yellow or greenish) sputum\n* CRP of 30 mg/l or above\n* PCT of 0,5 µg/l or above\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT02568358', 'briefTitle': 'DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection', 'orgStudyIdInfo': {'id': 'LuTx_Mibi-DNA-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Experimental Intervention: DNA-based testing of BAL fluid', 'type': 'OTHER', 'description': 'DNA based testing needs 4.5 hours lab time in addition to standard testing'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nora Drick, MD', 'role': 'CONTACT', 'email': 'drick.nora@mh-hannover.de', 'phone': '0511 532', 'phoneExt': '4601'}, {'name': 'Hoyer Susanne', 'role': 'CONTACT', 'email': 'hoyer.susanne@mh-hannover.de', 'phone': '0511 532', 'phoneExt': '4601'}], 'overallOfficials': [{'name': 'Jens Gottlieb, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Thomas Fühner', 'investigatorFullName': 'Thomas Fuehner', 'investigatorAffiliation': 'Hannover Medical School'}}}}