Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

University of Indonesia (UI)

Status and phase: Unknown; Phase 3

Conditions: Community-Acquired Pneumonia

Treatments: Drug: Simvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01651728

48/PT02.FK/ETIK/2012

U1111-1133-2403 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Simvastatin

Experimental group

Description:

Tablet 20 mg once daily for 30 days

Treatment:

Drug: Simvastatin

Placebo

Placebo Comparator group

Description:

Placebo tablet once daily for 30 days

Treatment:

Drug: Placebo