Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 8:44 PM
Study NCT ID:
NCT00946166
Status:
WITHDRAWN
Last Update Posted:
2015-04-22
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Statins on Cytokine Expression in Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigator left institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-20', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels', 'timeFrame': 'enrollment, 24h, 48h, 72h, hospital discharge'}], 'secondaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30-days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumonia', 'statins', 'cytokines'], 'conditions': ['Community Acquired Pneumonia', 'Cardiovascular Risk Factors']}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have pneumonia. The people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. Some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. The study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age,\n* Chart documentation by a clinician of an initial working diagnosis of pneumonia within 24 hours of admission,\n* Chest x-ray or other imaging evidence consistent with pneumonia within 48 hours of hospitalization, and\n* One of the following severity criteria: pneumonia severity index class III or higher, at least 2/5 components of the CURB-65, or ICU level care within 24 hours of admission.\n* Having one Food and Drug Agency approved indication for statin therapy\n\nExclusion Criteria:\n\n* Prior Treatment with one or more doses of a statin within 30-days prior to admission or during the current hospitalization.\n* Hospitalization \\> 24 hours at time of the diagnosis of pneumonia.\n* Hospitalization \\> 48 hours at time of study enrollment.\n* Residence in a skilled nursing facility.\n* Previously diagnosed human immunodeficiency virus infection with a current CD4 count \\< 200 cells/mm.\n* Immunosuppression\n* Patient or family decision to limit medical care ("comfort measures only").\n* Known allergy to statin therapy.\n* Active or planned pregnancy or breastfeeding.\n* Inability to take oral medications at the time of study enrollment.\n* Pre-existing liver disease or AST/ALT \\> 10% the upper limit of normal.\n* Creatinine phosphokinase (CPK or CK) \\> 50% above the upper limit of normal.\n* Partial ileal bypass.\n* Concurrent treatment with potential interacting drugs: ketoconazole, itraconazole, amiodarone, clarithromycin, erythromycin, cyclosporine, danazol, niacin, protease inhibitors, telithromycin, verapamil, gemfiborzil, ezetimibe (Zetia), nefazodone.\n* Transfer from an outside hospital.'}, 'identificationModule': {'nctId': 'NCT00946166', 'briefTitle': 'Impact of Statins on Cytokine Expression in Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Impact of Statins on Cytokine Expression in Pneumonia', 'orgStudyIdInfo': {'id': 'HSC2009-183H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'Subjects receive standard treatment for pneumonia and a simvastatin-like placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin', 'description': 'Subjects receive simvastatin in addition to standard pneumonia treatment', 'interventionNames': ['Drug: simvastatin']}], 'interventions': [{'name': 'simvastatin', 'type': 'DRUG', 'description': '40 mg daily in the evening for a maximum of 14 days', 'armGroupLabels': ['Simvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Simvastatin-like placebo administered daily in the evening for a maximum of 14 days', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Audie L Murphy Memorial Veterans Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Eric M Mortensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center/ South Texas Veterans Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}