Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00358202
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2006-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077723', 'term': 'Cefepime'}, {'id': 'D002443', 'term': 'Ceftriaxone'}], 'ancestors': [{'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': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-29', 'studyFirstSubmitDate': '2006-07-27', 'studyFirstSubmitQcDate': '2006-07-27', 'lastUpdatePostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total cost of all antibiotics.', 'timeFrame': '7-14 days'}], 'secondaryOutcomes': [{'measure': 'Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.', 'timeFrame': '7-14 days'}]}, 'conditionsModule': {'keywords': ['intramuscular antibiotics', 'nursing home acquired pneumonia', 'nhap', 'pharmacoeconomics', 'cefepime', 'ceftriaxone'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime is a safe, efficacious, and cost-effective alternative to once daily intramuscular ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do not require hospitalization.', 'detailedDescription': 'To compare the efficacy, safety, and pharmacoeconomics of cefepime versus ceftriaxone. Double-blind study of nursing home residents \\>60 years of age with pneumonia. Patients were randomized to cefepime or ceftriaxone 1 gm q24h to be administered intramuscularly. After three days, responding patients could be switched to oral antibiotics. Main Outcome Measures: clinical success, adverse events, and cost-effectiveness ratios.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Residents of a nursing home for \\>=30 days who were at least 60 years of age and developed pneumonia not amenable to oral antibiotics while not requiring hospitalization, a new infiltrate on chest Xray, estimated Clcr \\<=60 mL/min, presence of standard clinical criteria, signed informed consent.\n\nExclusion Criteria: Allergy to cephalosporins, receipt of \\>24 hours of an antibiotic (unless no improvement was evident), an existing infection due to a pathogen known resistant to either study drug; expected mortality within 48 hours, immunosuppression, hypotension or respiratory distress requiring ventilatory support, prior limited treatment or supportive care only directives, suspected or known Pseudomonas aeruginosa or MRSA infections, primary lung cancer or another malignancy metastatic to the lungs, bronchial obstruction or a history of post-obstructive pneumonia, or patients receiving renal dialysis.'}, 'identificationModule': {'nctId': 'NCT00358202', 'briefTitle': 'Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'CPL Associates'}, 'officialTitle': 'Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia', 'orgStudyIdInfo': {'id': 'NUR0300202A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 cefepime', 'interventionNames': ['Drug: cefepime']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 ceftriaxone', 'interventionNames': ['Drug: ceftriaxone']}], 'interventions': [{'name': 'cefepime', 'type': 'DRUG', 'description': 'cefepime hydrochloride 1gm IM q24h', 'armGroupLabels': ['1 cefepime']}, {'name': 'ceftriaxone', 'type': 'DRUG', 'description': 'ceftriaxone 1 gm IM q24h', 'armGroupLabels': ['2 ceftriaxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14226', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'CPL Associates,LLC', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Joseph A Paladino, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPL Associates, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CPL Associates', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elan Pharmaceuticals', 'class': 'INDUSTRY'}]}}}