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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1133-2403 | Registry Identifier | International Clinical Trials Registry Platform (WHO-ICTRP) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin | Experimental | Tablet 20 mg once daily for 30 days |
|
| Placebo | Placebo Comparator | Placebo tablet once daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Tablet 20 mg once daily for 30 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Death | 30 days |
| 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-Ï’) concentration | Baseline and 7 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuntjoro Harimurti, MD | Contact | +628159792380 | kuntjoro.harimurti01@ui.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Kuntjoro Harimurti, MD, MSc | Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Recruiting | Jakarta Pusat | Jakarta Special Capital Region | 10340 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19531550 | Background | 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. | |
| 18955636 | Background | 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. |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | daily for 30 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 |
| D008171 | Lung Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |