Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 2:15 PM
Study NCT ID:
NCT01975350
Status:
TERMINATED
Last Update Posted:
2021-03-16
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical cure rate', 'timeFrame': 'From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days', 'description': 'including clinical improvement and microbiological outcome(eradication of the pathogen as no growth of the pathogen in the final culture of specimens during the entire hospitalization)'}], 'secondaryOutcomes': [{'measure': 'intensive care unit stay', 'timeFrame': 'From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months'}, {'measure': 'hospital stay', 'timeFrame': 'From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months'}, {'measure': 'all cause mortality', 'timeFrame': 'From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days'}, {'measure': 'ventilator-associated pneumonia-related mortality', 'timeFrame': 'Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days'}, {'measure': 'microbiologic eradication in colonization patients', 'timeFrame': 'From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days'}, {'measure': 'ventilator-associated pneumonia rate', 'timeFrame': 'From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colistimethate sodium inhalation'], 'conditions': ['Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.', 'detailedDescription': 'Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in medical intensive care unit with ventilator use', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 20 years old\n2. medical ICU patients with invasive ventilator use ≥ 48 hours\n3. multidrug resistant Gram-negative bacteria obtained from lower respiratory tract\n\nExclusion Criteria:\n\n1. pregnancy\n2. concurrent use of other antimicrobial agents active for isolated multidrug resistant Gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam\n3. patients who refuse to receive any inhaled therapy'}, 'identificationModule': {'nctId': 'NCT01975350', 'briefTitle': 'Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria', 'orgStudyIdInfo': {'id': '201303119MINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colistimethate sodium inhalation', 'description': 'Colistimethate sodium inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.\n\nAdditional intravenous colistimethate sodium for patients with ventilator-associated pneumonia'}, {'label': 'saline inhalation', 'description': 'saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Wang-Huei Sheng, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Infection Control of National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}