Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-06-28 @ 8:20 PM
Study NCT ID:
NCT03622450
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Colistin Inhalation on 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': 'D015780', 'term': 'Carbapenems'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D015363', 'term': 'Quinolones'}], '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': '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': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Ventilatory status', 'timeFrame': '7 to 10 days', 'description': 'Pf ratio measurement'}], 'secondaryOutcomes': [{'measure': 'Days of mechanical ventilation', 'timeFrame': '35 Days', 'description': 'Deescalation in the ventilation mode and trials until successful weaning.'}, {'measure': 'Time till the occurence of sepsis', 'timeFrame': '35 Days', 'description': 'long standing ventilator associated pneumonia with failure of treatment can lead to sepsis'}, {'measure': 'Mortality as an outcome of long stand untreatable ventilator associated pneumonia', 'timeFrame': '35 days', 'description': 'is the mortality due to sepsis of other causes'}, {'measure': 'Length of stay in the icu', 'timeFrame': '35 days', 'description': 'How long will the patient stay in the ICU according to failure of weaning and progression of the disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years\n\nPatients presenting with signs of infection 48 hours of intubation\n\nExclusion Criteria:\n\n* Patients with documented bronchiectasis\n\nCystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.\n\nPatients with creatinine clearance less than 30ml/min.'}, 'identificationModule': {'nctId': 'NCT03622450', 'briefTitle': 'The Effect of Colistin Inhalation on Ventilator Associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia', 'orgStudyIdInfo': {'id': 'Colistin inhalation form'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medication arm', 'description': 'Colistin to be given as 2 millions three times daily in the inhalation form from 5 to 7 days in addition to another antipseudomonal antibiotic according to infectious disease society of antimicrobials (IDSA) guidelines from day 1 of incidence of ventilator associated pneumonia', 'interventionNames': ['Drug: Colistin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Patients receive antipseudomonal antibiotics IV as carbapenem and quinolone or aminoglycoside according to IDSA guidelines from day 1 of incidence of Ventilator associated pneumonia carbapenem as 1g three times daily + tavanic 750mg once daily or ciprofloxacin 500mg twice daily or aminoglycoside according to renal function', 'interventionNames': ['Drug: Carbapenem + Aminoglycoside/ Quinolone']}], 'interventions': [{'name': 'Colistin', 'type': 'DRUG', 'otherNames': ['Colomycin'], 'description': 'Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.', 'armGroupLabels': ['Medication arm']}, {'name': 'Carbapenem + Aminoglycoside/ Quinolone', 'type': 'DRUG', 'otherNames': ['tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin'], 'description': 'Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors', 'armGroupLabels': ['Control arm']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Number of patients ,statistical data, method,discussion and outcome will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan Hassan Osama Thuraya Mohamed', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical pharmacist', 'investigatorFullName': 'Nourhan Hassan Osama Thuraya Mohamed', 'investigatorAffiliation': 'Ain Shams University'}}}}