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

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.

Study Overview

• Status: Unknown
• Conditions: Community-Acquired Pneumonia
• Intervention / Treatment: Drug: Simvastatin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10340
      • Recruiting
      • Cipto Mangunkusumo hospital
      • Contact: Kuntjoro Harimurti, MD; Phone Number: +628159792380; Email: kuntjoro.harimurti01@ui.ac.id
      • Principal Investigator: Kuntjoro Harimurti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simvastatin; Tablet 20 mg once daily for 30 days	Drug: Simvastatin; Tablet 20 mg once daily for 30 days; Other Names: CAS Number 79902-63-9; ATC Code C10AA01
Placebo Comparator: Placebo; Placebo tablet once daily for 30 days	Drug: Placebo; daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death	30 days

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Kuntjoro Harimurti, MD, MSc, Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): August 6, 2012
• Last Update Submitted That Met QC Criteria: August 2, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Elderly; Pneumonia; Simvastatin; CRP; TNF-α; PAI-1; IFN-ϒ
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: 48/PT02.FK/ETIK/2012; U1111-1133-2403 (Registry Identifier: International Clinical Trials Registry Platform (WHO-ICTRP))