NCT01651728

Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Community-Acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Simvastatin	Tablet 20 mg once daily for 30 days
DRUG	Placebo	daily for 30 days

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-07-27
• Last updated: 2012-08-06

Locations

1 site across 1 country: Indonesia