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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01651728

Enrollment

200

Registered

2012-07-27

Start date

2012-07-31

Completion date

2013-09-30

Last updated

2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-Acquired Pneumonia

Keywords

Simvastatin, Pneumonia, Elderly, TNF-α, IFN-ϒ, PAI-1, CRP

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.

Interventions

DRUGSimvastatin

Tablet 20 mg once daily for 30 days

DRUGPlacebo

daily for 30 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Death	30 days

Secondary

Measure	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

Countries

Indonesia

Contacts

Primary ContactKuntjoro Harimurti, MD

kuntjoro.harimurti01@ui.ac.id+628159792380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026