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


Phase 3
60 Years
N/A
Open (Enrolling)
Both
Community-Acquired Pneumonia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Death

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Kuntjoro Harimurti, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia

Authority:

Indonesia: Departement Kesehatan (Department of Health)

Study ID:

48/PT02.FK/ETIK/2012

NCT ID:

NCT01651728

Start Date:

July 2012

Completion Date:

September 2013

Related Keywords:

  • Community-Acquired Pneumonia
  • Simvastatin
  • Pneumonia
  • Elderly
  • TNF-α
  • IFN-ϒ
  • PAI-1
  • CRP
  • Pneumonia

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