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Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01651728
Recruitment Status : Unknown
Verified August 2012 by Kuntjoro Harimurti, Indonesia University.
Recruitment status was:  Recruiting
First Posted : July 27, 2012
Last Update Posted : August 6, 2012
Information provided by (Responsible Party):
Kuntjoro Harimurti, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Community-Acquired Pneumonia Drug: Simvastatin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Simvastatin

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

Primary Outcome Measures :
  1. Death [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration [ Time Frame: Baseline and 7 days ]
  2. Change from baseline in Interferon-gamma (INF-ϒ) concentration [ Time Frame: Baseline and 7 days ]
  3. Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration [ Time Frame: Baseline and 7 days ]
  4. Change from baseline in C-Reactive Protein (CRP) concentration [ Time Frame: Baseline and 7 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01651728

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Contact: Kuntjoro Harimurti, MD +628159792380

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Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, Jakarta, Indonesia, 10340
Contact: Kuntjoro Harimurti, MD    +628159792380   
Principal Investigator: Kuntjoro Harimurti, MD         
Sponsors and Collaborators
Indonesia University
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Principal Investigator: Kuntjoro Harimurti, MD, MSc Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
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Responsible Party: Kuntjoro Harimurti, M.D., M.Sc., Indonesia University Identifier: NCT01651728    
Other Study ID Numbers: 48/PT02.FK/ETIK/2012
U1111-1133-2403 ( Registry Identifier: International Clinical Trials Registry Platform (WHO-ICTRP) )
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012
Keywords provided by Kuntjoro Harimurti, Indonesia University:
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors