Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT01280461
Status:
UNKNOWN
Last Update Posted:
2011-01-20
First Post:
2011-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-19', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumonia'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'This is a phase III, multi-center, open-label, comparative and randomized study in evaluating the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will determine the total duration of study therapy, as clinically indicated. The minimum duration of study therapy will be 7 days and the maximum allowable duration of study therapy will be 21 days.', 'detailedDescription': 'Patients fulfill inclusion/exclusion criteria will be randomly assigned (in a 1:1 ratio)to receive intravenous cefoperazone/sulbactam or intravenous cefepime for 7\\~21days. Vitamin K1 10mg will be administered to cefoperazone/sulbactam group every 24 hours.\n\nThe assessment of clinical sign and symptoms of pneumonia and microbiological tests will be performed at early post-therapy visit and test-of-cure visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with nosocomial bacterial pneumonia or healthcare-associated pneumonia(HCAP)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients aged ≧18 years old\n* Patients with nosocomial bacterial pneumonia at least 48 hours after hospitalization or patients with healthcare-associated pneumonia(HCAP\\*).\n* Clinical findings\n\nAt least two of the following signs:\n\n1. Cough\n2. Fever: axillary temperature \\> 37.5℃ or tympanic temperature \\> 38.5℃\n3. Hypothermia: axillary temperature \\< 34℃ or tympanic temperature \\< 35℃\n4. Purulent sputum production or respiratory secretion\n5. Total peripheral white blood cell (WBC) count \\> 10,000/mm3; or \\> 15% band forms, regardless of total peripheral white count; or leucopenia with total WBC \\< 4500/mm3\n6. Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)\n7. Hypoxemia (defined as a partial O2 pressure \\<60 mmHg while the patient was breathing normal air or a decrease in the partial O2 pressure of ≧25% from an initial value)\n\n * Radiographic findings The chest radiograph should show the presence of a new or progressive infiltration on the chest X-ray film\n * Microbiologic criteria If sputum specimen is available and collected, both tests are mandatory with at least one of the following results is positive:\n\n(1) Within 24 hours prior to, or at the time of enrollment, all patients should have had a culture and susceptibility testing of respiratory secretions or sputum to study drugs (2)Gram stain of respiratory secretions or sputum\n\n* Patient must be able to sign a written informed consent form prior to the start of the study procedures. If any patient is unable to give consent, it must be obtained from the patient's legal representative\n* Subject has not received more than 24 hours of a parenteral antibacterial drug for the current pneumonia. If subject has received more than 24 hours of a parenteral antibacterial drug, he/she must be declared as treatment failure.\n\nExclusion Criteria:\n\n* Woman who are pregnant (determined by urine test) or lactating state\n* Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease)\n* A neutrophil count \\<1000/mm3\n* Patients with pneumonia due to viral, fungal, or mycobacterial infection.\n* Patients who were known to have been infected with human immunodeficiency virus\n* Documented Legionella pneumonia\n* Patients were infected with gram negative (G-) microorganism known to be resistant to one of the study antibiotics during trial\n* Subjects with sputum gram stain of PMN\\>25, epithelial cell \\<10, and gram positive (G+) cocci in cluster predominant and phagocytosis\n* Patients who have received any other investigational drug within 30 days prior to enrollment\n* Patients who have received medications like cefoperazone, cefoperazone/sulbactam and cefepime within 30 days prior to enrollment\n* Patients with abnormal pre-therapy laboratory data: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≧ 3X ULN (upper limit of normal); or serum creatinine, urea nitrogen \\> 3X ULN\n* A history of hypersensitivity to penicillins, cephalosporins, carbapenems or J-lactam/J-lactamase inhibitors\n* Severe disease (eg. septic shock, acute respiratory distress syndrome, and multiple organ failure) which may limit survival during therapy and follow-up period, or confound the results of the study as judged by the investigator"}, 'identificationModule': {'nctId': 'NCT01280461', 'briefTitle': 'An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia', 'orgStudyIdInfo': {'id': '99067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental Group'}, {'label': 'Control Group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University - WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Wen-Sen Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University WanFang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wen-Sen Lee', 'oldOrganization': 'Department of Infectious Diseases, WanFang Hospital'}}}}