Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00786305
Status:
COMPLETED
Last Update Posted:
2008-11-06
First Post:
2008-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D011552', 'term': 'Pseudomonas Infections'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'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': 'D002442', 'term': 'Ceftazidime'}, {'id': 'D000583', 'term': 'Amikacin'}], 'ancestors': [{'id': 'D002509', 'term': 'Cephaloridine'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'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': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-05', 'studyFirstSubmitDate': '2008-11-05', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial killing', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Changes of lung aeration', 'timeFrame': '8 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nebulization', 'ceftazidime', 'amikacin', 'pneumonia', 'Pseudomonas aeruginosa', 'mechanical ventilation', 'Ventilator-associated pneumonia', 'treatment'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female \\>18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa\n* Written informed consent provided by the relatives\n\nExclusion Criteria:\n\n* Pseudomonas aeruginosa resistant to ceftazidime and amikacin\n* Pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment\n* Severe septic shock and severe hypoxemia\n* Allergy to ceftazidime or amikacin'}, 'identificationModule': {'nctId': 'NCT00786305', 'briefTitle': 'Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Pitie-Salpetriere'}, 'officialTitle': 'Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa', 'orgStudyIdInfo': {'id': 'NATB-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: nebulized ceftazidime and amikacin', 'interventionNames': ['Drug: ceftazidime and amikacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: intravenous ceftazidime and amikacin', 'interventionNames': ['Drug: ceftazidime and amikacin']}], 'interventions': [{'name': 'ceftazidime and amikacin', 'type': 'DRUG', 'otherNames': ['fortum and amiklin'], 'description': 'Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days', 'armGroupLabels': ['1: nebulized ceftazidime and amikacin']}, {'name': 'ceftazidime and amikacin', 'type': 'DRUG', 'otherNames': ['fortum and amiklin'], 'description': 'Intravenous infusion of ceftazidime 30 mg/kg over 30 min followed by continuous infusion 90 mg/kg/day during 8 days and intravenous infusion of amikacin 15 mg/kg/day over 30 min during 3 days', 'armGroupLabels': ['2: intravenous ceftazidime and amikacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Jacques Rouby, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Pitie-Salpetriere hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Jacques Rouby', 'oldOrganization': 'Groupe Hospitalier Pitie-Salpetriere'}}}}