Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

Study Overview
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Brief Summary
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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. The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia.

Detailed Description
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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. 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.

Official Title
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Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients: A Study of Immunological, Inflammatory, and Coagulation Responses in Relation to Reduce Mortality During Hospitalization

Conditions
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Community-Acquired Pneumonia

Intervention / Treatment
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* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients with pneumonia Exclusion Criteria: Severe septic condition 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin<br>Tablet 20 mg once daily for 30 days | Drug: Simvastatin<br>* Tablet 20 mg once daily for 30 days<br>* Other names: ATC Code C10AA01;|
| Placebo Comparator: Placebo<br>Placebo tablet once daily for 30 days | Drug: Placebo<br>* daily for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration |  | Baseline and 7 days | 
| Change from baseline in Interferon-gamma (INF-ϒ) concentration |  | Baseline and 7 days | 
| Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration |  | Baseline and 7 days | 
| Change from baseline in C-Reactive Protein (CRP) concentration |  | Baseline and 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simvastatin, Pneumonia, Elderly, TNF-α, IFN-ϒ, PAI-1, CRP