Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

Community-Acquired Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01651728
• Other study ID #: 48/PT02.FK/ETIK/2012
• Secondary ID: U1111-1133-2403
• Status: Recruiting
• Phase: Phase 3
• First received: July 24, 2012
• Last updated: August 2, 2012
• Start date: July 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2012
• Source: Indonesia University
• Contact: Kuntjoro Harimurti, MD
• Phone: +628159792380
• Email: kuntjoro.harimurti01[@]ui.ac.id
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Community-Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Simvastatin
Tablet 20 mg once daily for 30 days
• Placebo
daily for 30 days

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View Citation

Thomsen RW, Riis A, Kornum JB, Christensen S, Johnsen SP, Sørensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		30 days	No
Secondary	Change from baseline in TNF-a (Tumor Necrosis Factor alpha) concentration		Baseline and 7 days	No
Secondary	Change from baseline in Interferon-gamma (INF-?) concentration		Baseline and 7 days	No
Secondary	Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration		Baseline and 7 days	No
Secondary	Change from baseline in C-Reactive Protein (CRP) concentration		Baseline and 7 days	No