Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-30 @ 3:36 AM
Study NCT ID:
NCT01027832
Status:
UNKNOWN
Last Update Posted:
2009-12-09
First Post:
2009-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010878', 'term': 'Piperacillin'}, {'id': 'D000078142', 'term': 'Tazobactam'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010397', 'term': 'Penicillanic Acid'}, {'id': 'D013450', 'term': 'Sulfones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-08', 'studyFirstSubmitDate': '2009-11-26', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of development of new pneumonia', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay (LOS) and mortality', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tracheobronchitis'], 'conditions': ['Tracheobronchitis']}, 'descriptionModule': {'briefSummary': 'Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever, and purulent sputum, but without radiological evidence of pneumonia.\n\nThese patients may have tracheobronchitis. Some suspect that this condition precedes the development of pneumonia. Antibiotic treatment in tracheobronchitis is controversial.\n\nThe investigators will recruit patients with tracheobronchitis and randomize them into 2 groups. One group will be treated with antibiotics and the other group will serve as control.', 'detailedDescription': 'Patients with proved tracheobronchitis who are mechanically ventilated for more than 48 hrs, will undergo a CT scan to rool our pneumonia that may not be seen on a routine chest x-ray.\n\nAfter ruling out pneumonia by CT scan, patients will be randomized into 2 groups. Intervention group will receive 7 days of treatment with Piperacillin/Tazobactam. A control group will receive nothing.\n\nPrimary endpoint wil be the rate of new pneumonias and secondary endpoint will be ICU Length of stay, days on mechanical ventilation and 28 day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tracheobronchitis as defined by:\n\n * Purulent sputum with \\> 10 x 4 CFU\n * Leukocytosis or leukopenia\n * Fever\n * No pneumonia on CT scan\n\nExclusion Criteria:\n\n* Recent treatment of pneumonia\n* Abnormal Chest X-ray\n* Evidence of Pneumonia on CT scan'}, 'identificationModule': {'nctId': 'NCT01027832', 'briefTitle': 'Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '102/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'antibiotics', 'interventionNames': ['Drug: Piperacillin/Tazobactam for 7 days']}], 'interventions': [{'name': 'Piperacillin/Tazobactam for 7 days', 'type': 'DRUG', 'description': 'Piperacillin/Tazobactam for 7 days', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Beer Yakov', 'state': 'Zerifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arie Soroksky, M.D.', 'role': 'CONTACT', 'email': 'soroksky@gmail.com', 'phone': '972-8-9779320'}, {'name': 'Arie Soroksky, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assaf Harofe MC'}], 'centralContacts': [{'name': 'Arie Soroksky, MD', 'role': 'CONTACT', 'email': 'soroksky@gmail.com', 'phone': '972-8-9779320'}], 'overallOfficials': [{'name': 'Arie Soroksky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University, Faculty of Medicine, Israel.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Arie Soroksky M.D.', 'oldOrganization': 'AGeneral ICU, Assaf Harofe MC, Zerifin 70300, Israel'}}}}