Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01802827
Status:
COMPLETED
Last Update Posted:
2013-03-01
First Post:
2012-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ventilator Associated Tracheobronchitis in the First 14 Days in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood, sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-28', 'studyFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'mortality at 4 weeks', 'description': 'we assessed mortality from all causes at 4 weeks'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': 'expected average length of stay 15 days'}, {'measure': 'mortality at 6 months', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['airway colonization', 'tracheobronchitis', 'pneumonia'], 'conditions': ['Airway Colonization', 'Tracheobronchitis and Pneumonia Associated With Ventilator']}, 'descriptionModule': {'briefSummary': 'To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients ventilated \\> 48hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 48 hours mechanical ventilation\n\nExclusion Criteria:\n\n* immunodeficiency\n* pregnancy\n* severe COPD, chronic bronchitis, bronchiectasis\n* recent pneumonia'}, 'identificationModule': {'nctId': 'NCT01802827', 'briefTitle': 'Ventilator Associated Tracheobronchitis in the First 14 Days in ICU', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'orgStudyIdInfo': {'id': 'MARKAR236'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VAT patients', 'description': 'Patients developing Ventilator Associated Tracheobronchitis'}, {'label': 'VAP', 'description': 'Patients presenting ventilator associated pneumonia'}, {'label': 'No ventilator associated infection', 'description': 'patients who do not present ventilator associated infection during their stay in ICU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph, Principal Investigator', 'investigatorFullName': 'Efstratios Manoulakas', 'investigatorAffiliation': 'University of Thessaly'}}}}