Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-07 @ 3:48 PM
Study NCT ID:
NCT02728518
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2016-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-17', 'releaseDate': '2017-09-16'}], 'estimatedResultsFirstSubmitDate': '2017-09-16'}}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2016-04-04', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group', 'timeFrame': 'through study completion, over one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': "The investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli", 'detailedDescription': 'prospective, randomized, controlled study on post-cardiac surgery patients , included two groups, over one year period. The first group was administered intravenous (IV) amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered intravenous (IV) piperacillin/tazobactam empirically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to ICU\n* Clinical suspicion of VAP or HAP defined by a new persistent radiological infiltrate and one of the following signs:\n* purulent tracheal aspirations, or\n* temperature of 38° or higher, or leucocyte count \\> 10000/ml or\n* Positive culture sensitive to amikacin\n* In case of empirical treatment, risk of multi resistant bacteria defined as follows:\n* Antimicrobial therapy in preceding 90 days and\n* Current hospitalization of 5 d or more\n\nExclusion Criteria:\n\n* History of Asthma\n* Multi organ failure or any psychiatric illness\n* allergy to amikacin or intolerance to nebulized amikacin\n* Myasthenia gravis.\n* Severely impaired renal function (creatinine clearance lower than 10 mL/min or renal replacement therapy)\n* Vestibulo-cochlear disease.\n* Pregnancy.\n* Brain death'}, 'identificationModule': {'nctId': 'NCT02728518', 'briefTitle': 'Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Heart Institute, Egypt'}, 'officialTitle': 'Evaluation of the Safety and Efficacy of Nebulized Amikacin as Adjunctive Therapy in Hospital Acquired and Ventilator Associated Bacterial Pneumonia in Surgical Intensive Care Units', 'orgStudyIdInfo': {'id': 'NHI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized Amikacin', 'description': 'patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam', 'interventionNames': ['Drug: Nebulized Amikacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amikacin Intravenous', 'description': 'patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam', 'interventionNames': ['Drug: Intravenous Amikacin']}], 'interventions': [{'name': 'Nebulized Amikacin', 'type': 'DRUG', 'description': '400mg twice daily nebulized amikacin', 'armGroupLabels': ['Nebulized Amikacin']}, {'name': 'Intravenous Amikacin', 'type': 'DRUG', 'description': '20mg/kg once daily intravenous amikacin', 'armGroupLabels': ['Amikacin Intravenous']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nehal A Hassan, BCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart Institute'}, {'name': 'Faten F El sayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart Institute'}, {'name': 'Nirmeen A Sabry, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart Institute, Egypt', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacotherapy Specialist', 'investigatorFullName': 'NKhalek', 'investigatorAffiliation': 'National Heart Institute, Egypt'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-16', 'type': 'RELEASE'}, {'date': '2017-10-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'NKhalek, Pharmacotherapy Specialist, National Heart Institute, Egypt'}}}}