Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-03 @ 4:42 PM
Study NCT ID:
NCT01651728
Status:
UNKNOWN
Last Update Posted:
2012-08-06
First Post:
2012-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2012-07-24', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration', 'timeFrame': 'Baseline and 7 days'}, {'measure': 'Change from baseline in Interferon-gamma (INF-ϒ) concentration', 'timeFrame': 'Baseline and 7 days'}, {'measure': 'Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration', 'timeFrame': 'Baseline and 7 days'}, {'measure': 'Change from baseline in C-Reactive Protein (CRP) concentration', 'timeFrame': 'Baseline and 7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Simvastatin', 'Pneumonia', 'Elderly', 'TNF-α', 'IFN-ϒ', 'PAI-1', 'CRP'], 'conditions': ['Community-Acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '19531550', 'type': 'BACKGROUND', 'citation': 'Dublin S, Jackson ML, Nelson JC, Weiss NS, Larson EB, Jackson LA. Statin use and risk of community acquired pneumonia in older people: population based case-control study. BMJ. 2009 Jun 16;338:b2137. doi: 10.1136/bmj.b2137.'}, {'pmid': '18955636', 'type': 'BACKGROUND', 'citation': 'Thomsen RW, Riis A, Kornum JB, Christensen S, Johnsen SP, Sorensen HT. Preadmission use of statins and outcomes after hospitalization with pneumonia: population-based cohort study of 29,900 patients. Arch Intern Med. 2008 Oct 27;168(19):2081-7. doi: 10.1001/archinte.168.19.2081.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to assess the effect of simvastatin on immunology, inflammatory, and coagulation responses, and mortality in elderly with pneumonia based. The primary outcome is mortality event.\n\nThe hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia.', 'detailedDescription': 'Elderly patients diagnosed with pneumonia after getting information and signing informed consent will be included in this trial. Simvastatin 20 mg will be administered to intervention group, while control group will receive placebo. Both groups will receive drugs (or placebo) for 30 days.\n\nBaseline data will be collected within 24 hours after admission. Then the subject will be followed up for 30 days. At the 7th day, patients will be underwent several laboratory tests, i.e. serum TNF-α (Tumor Necrosis Factor alpha), IFN-ϒ Interferon gamma), CRP (C-Reactive Protein), and PAI-1 (Plasminogen Activator Inhibitor-1). Death from all causes until 30 days will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly patients with pneumonia\n\nExclusion Criteria:\n\n* Severe septic condition\n* Hepatic Cirrhosis\n* Acute coronary disease\n* Total cholesterol which is too high or too low\n* In anticoagulant therapy\n* In steroid therapy or other immunosuppressant therapy\n* Have refused to join the study'}, 'identificationModule': {'nctId': 'NCT01651728', 'briefTitle': 'Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients: A Study of Immunological, Inflammatory, and Coagulation Responses in Relation to Reduce Mortality During Hospitalization', 'orgStudyIdInfo': {'id': '48/PT02.FK/ETIK/2012'}, 'secondaryIdInfos': [{'id': 'U1111-1133-2403', 'type': 'REGISTRY', 'domain': 'International Clinical Trials Registry Platform (WHO-ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simvastatin', 'description': 'Tablet 20 mg once daily for 30 days', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet once daily for 30 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['CAS Number 79902-63-9', 'ATC Code C10AA01'], 'description': 'Tablet 20 mg once daily for 30 days', 'armGroupLabels': ['Simvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'daily for 30 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10340', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Kuntjoro Harimurti, MD', 'role': 'CONTACT', 'email': 'kuntjoro.harimurti01@ui.ac.id', 'phone': '+628159792380'}, {'name': 'Kuntjoro Harimurti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Kuntjoro Harimurti, MD', 'role': 'CONTACT', 'email': 'kuntjoro.harimurti01@ui.ac.id', 'phone': '+628159792380'}], 'overallOfficials': [{'name': 'Kuntjoro Harimurti, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., M.Sc.', 'investigatorFullName': 'Kuntjoro Harimurti', 'investigatorAffiliation': 'Indonesia University'}}}}