- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651728
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
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kuntjoro Harimurti, MD
- Phone Number: +628159792380
- Email: kuntjoro.harimurti01@ui.ac.id
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Simvastatin
Tablet 20 mg once daily for 30 days
|
Tablet 20 mg once daily for 30 days
Other Names:
|
Placebo Comparator: Placebo
Placebo tablet once daily for 30 days
|
daily for 30 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration
Time Frame: Baseline and 7 days
|
Baseline and 7 days
|
Change from baseline in Interferon-gamma (INF-ϒ) concentration
Time Frame: Baseline and 7 days
|
Baseline and 7 days
|
Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration
Time Frame: Baseline and 7 days
|
Baseline and 7 days
|
Change from baseline in C-Reactive Protein (CRP) concentration
Time Frame: Baseline and 7 days
|
Baseline and 7 days
|
Collaborators and Investigators
Sponsor
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
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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