Clinical trial NCT01651728: Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
Official title: Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients: A Study of Immunological, Inflammatory, and Coagulation Responses in Relation to Reduce Mortality During Hospitalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Community-Acquired Pneumonia
Keywords: Simvastatin
Pneumonia
Elderly
TNF-α
IFN-ϒ
PAI-1
CRP
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death
timeFrame: 30 days
Secondary outcomes:
measure: Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration
timeFrame: Baseline and 7 days
measure: Change from baseline in Interferon-gamma (INF-ϒ) concentration
timeFrame: Baseline and 7 days
measure: Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration
timeFrame: Baseline and 7 days
measure: Change from baseline in C-Reactive Protein (CRP) concentration
timeFrame: Baseline and 7 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
affiliation: Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
name: Kuntjoro Harimurti, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.