Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
NCT ID: NCT01651728
Last Updated: 2012-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2012-07-31
2013-09-30
Brief Summary
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The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia.
Detailed Description
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Baseline 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Simvastatin
Tablet 20 mg once daily for 30 days
Simvastatin
Tablet 20 mg once daily for 30 days
Placebo
Placebo tablet once daily for 30 days
Placebo
daily for 30 days
Interventions
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Simvastatin
Tablet 20 mg once daily for 30 days
Placebo
daily for 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hepatic Cirrhosis
* Acute coronary disease
* Total cholesterol which is too high or too low
* In anticoagulant therapy
* In steroid therapy or other immunosuppressant therapy
* Have refused to join the study
60 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Kuntjoro Harimurti
M.D., M.Sc.
Principal Investigators
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Kuntjoro Harimurti, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Locations
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Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Kuntjoro Harimurti, MD
Role: primary
References
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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.
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.
Other Identifiers
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U1111-1133-2403
Identifier Type: REGISTRY
Identifier Source: secondary_id
48/PT02.FK/ETIK/2012
Identifier Type: -
Identifier Source: org_study_id