Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02683603
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aerosolised Colistin in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003091', 'term': 'Colistin'}, {'id': 'D015378', 'term': 'Imipenem'}, {'id': 'D011208', 'term': 'Powders'}], 'ancestors': [{'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '28 days'}], 'primaryOutcomes': [{'measure': 'cure of VAP', 'timeFrame': 'day 14 of therapy', 'description': 'a CPIS (clinical pulmonary infection score) less than 6 and bacterial eradication'}], 'secondaryOutcomes': [{'measure': 'occurrence of acute renal failure', 'timeFrame': 'From date of randomization until the time of the cessation of colistin, assessed up 14 days on average', 'description': 'an acute renal failure was defined as increase of plasma creatinine more than 1.5 times its base value.'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'From date of randomization until the time of weaning from ventilator, an average of 14 days'}, {'measure': 'length of stay in intensive unit', 'timeFrame': 'from randomisation until the time of patient discharge, an average of 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colistin', 'aerosol', 'ventilator associated pneumonia', 'nephrotoxicity', 'intravenous'], 'conditions': ['Pneumonia, Ventilator-Associated']}, 'referencesModule': {'references': [{'pmid': '27033711', 'type': 'DERIVED', 'citation': 'Abdellatif S, Trifi A, Daly F, Mahjoub K, Nasri R, Ben Lakhal S. Efficacy and toxicity of aerosolised colistin in ventilator-associated pneumonia: a prospective, randomised trial. Ann Intensive Care. 2016 Dec;6(1):26. doi: 10.1186/s13613-016-0127-7. Epub 2016 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'the management of Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR) gram-negative bacilli (GNB) represent a real therapeutic dilemma in intensive care unit (ICU). Colistin remains an effective agent against MDR GNB. However, because of its side effects, mainly nephrotoxicity, other modalities than the intra venous (IV) route should be tried. Several recent data emphasize the interest of inhaled route. The investigators purpose was to evaluate the effectiveness and systemic toxicity of aerosolized colistin in ventilator associated pneumonia.', 'detailedDescription': 'prospective, randomized, single-blind study comparing two groups of patients treated with aerosolised (AS) colistin versus colistin intravenously (IV). Included were patients who have mechanical ventilation over 48 hours and that have developed a VAP. A VAP was defined as a CPIS (Clinical Pulmonary Infection Score) \\>6. Exclusion criteria were septic shock and/or bacteraemia. Included patients were divided into two randomized groups. The 1st received colistin in AS as 4 MU by nebulisation 3 times per 24 h. The 2nd received colistin in IV as a loading dose of 9 MU followed by 4.5MU two times per 24 h. Colistin was given for 14 days or until extubation. Patients were followed for 28 days. Therapeutic efficacy was assessed by a primary outcome: the cure of VAP at day 14 of therapy and defined as resolution of clinical and biological signs of infection that means a CPIS\\< 6 and bacteriological eradication. Secondary outcomes: duration of mechanical ventilation, ICU stay-length and mortality at day 28. Systemic toxicity was assessed by the occurrence of acute renal failure (ARF) defined as increase of plasma creatinine more than 1.5 times its base value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill patients older than 18 years, with mechanical ventilation during more than 48 hours, and who have presented a Ventilator associated Pneumonia (VAP) defined as a CPIS (Clinical Pulmonary Infection Score) of more than six\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Pregnancy\n* Septic shock'}, 'identificationModule': {'nctId': 'NCT02683603', 'briefTitle': 'Effect of Aerosolised Colistin in Ventilator Associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Efficacy and Toxicity of Aerosolised Colistin in Ventilator Associated Pneumonia: A Prospective, Randomized Trial', 'orgStudyIdInfo': {'id': 'Tunis university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aerosolised (AS) colistin group', 'description': 'the intervention was: AS colistin and "imipenem. the drug administered was colimycin (colistin) powder 1 million units (MU) by a flakon (Sanofi Winthrop Industry) at the dosage of 4 million units (MU) for 30 minutes 3 times per day for at least 14 days in addition to IV imipenem 1 g three times per day. Nebulisation was made via an ultrasonic vibrating plates nebulizer (Aeroneb Pro® Aerogen Nektar Corporation, Galway, Ireland). Inhaled colimycin® requires specific settings of the ventilator to limit turbulence inspiratory flow. The adjustment consisted in a volume controlled mode with a Tidal volume \\<8 ml / kg, respiratory rate at 12 cycles / min, I / E: 1/1 and an end inspiratory break \\> 20%.', 'interventionNames': ['Drug: AS colistin and "imipenem"', 'Drug: AS colimycin (colistin)', 'Drug: AS colistin and imipenem']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous (IV) colistin goup', 'description': 'the intervention was: IV colistin and "imipenem. the intravenous (IV) colistin goup received IV colimycin (colistin) as a loading dose of 9 MU during 60 minutes followed by 4.5 million units 2 times per day in addition to IV imipenem 1 g three times per day.', 'interventionNames': ['Drug: IV colistin " and "imipenem" .', 'Drug: IV colimycin (colistin)', 'Drug: IV colistin and imipenem']}], 'interventions': [{'name': 'AS colistin and "imipenem"', 'type': 'DRUG', 'otherNames': ['colimycin (colistin) powder (Sanofi laboratories)'], 'description': 'colimycin (colistin) powder (1 million units (MU) by flakon) by AS route in addition to imipenem', 'armGroupLabels': ['aerosolised (AS) colistin group']}, {'name': 'IV colistin " and "imipenem" .', 'type': 'DRUG', 'otherNames': ['colimycin (colistin) powder (Sanofi laboratories)'], 'description': 'colimycin (colistin) powder (1 MU by flakon) by intravenous route in addition to imipenem', 'armGroupLabels': ['intravenous (IV) colistin goup']}, {'name': 'AS colimycin (colistin)', 'type': 'DRUG', 'otherNames': ['colimycin (colistin)'], 'description': 'nebulisation of colimycin (colistin) for 30 minutes 3 times per day during at least 14 days. Nebulisation was made via an ultrasonic vibrating plates nebulizer (Aeroneb Pro® Aerogen Nektar Corporation, Galway, Ireland).', 'armGroupLabels': ['aerosolised (AS) colistin group']}, {'name': 'IV colimycin (colistin)', 'type': 'DRUG', 'otherNames': ['colimycin (colistin) powder by intravenous route'], 'description': 'intravenous colimycin (colistin) : 9 MU during 60 minutes followed by 4.5 million units 2 times per day', 'armGroupLabels': ['intravenous (IV) colistin goup']}, {'name': 'AS colistin and imipenem', 'type': 'DRUG', 'otherNames': ['imipenem'], 'description': 'IV imipenem 1 g three times per day.', 'armGroupLabels': ['aerosolised (AS) colistin group']}, {'name': 'IV colistin and imipenem', 'type': 'DRUG', 'otherNames': ['imipenem'], 'description': 'IV imipenem 1 g three times per day', 'armGroupLabels': ['intravenous (IV) colistin goup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1007', 'city': 'Tunis', 'state': 'Tunis Governorate', 'country': 'Tunisia', 'facility': 'intensive care unit of the University Hospital Center La Rabta', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Ahlem Trifi', 'role': 'STUDY_CHAIR', 'affiliation': 'Tunis University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'yes of course the data is collected on individual cards which identified demographic, clinical and laboratory data for each patient participating. thereafter these data is entered on Statistical Package for Social Sciences (SPSS) software'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Ahlem Trifi', 'investigatorAffiliation': 'Tunis University'}}}}