Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

Phase 3

• Conditions: Community-Acquired Pneumonia
• Interventions: Drug: Placebo; Drug: Simvastatin

• Registration Number: NCT01651728
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-02
• Last Update Posted: 2012-08-06
• Primary Completion: 2013-08
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet once daily for 30 days
Simvastatin	Simvastatin	Tablet 20 mg once daily for 30 days

Primary Outcome Measures

Name	Time	Method
Death	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia