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Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

This study is currently recruiting participants.
Verified August 2012 by Indonesia University
Sponsor:
Information provided by (Responsible Party):
Kuntjoro Harimurti, Indonesia University
ClinicalTrials.gov Identifier:
NCT01651728
First received: July 24, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Community-Acquired Pneumonia
 Drug: Simvastatin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • Death [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration [ Time Frame: Baseline and 7 days ] [ Designated as safety issue: No ]
  • Change from baseline in Interferon-gamma (INF-ϒ) concentration [ Time Frame: Baseline and 7 days ] [ Designated as safety issue: No ]
  • Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration [ Time Frame: Baseline and 7 days ] [ Designated as safety issue: No ]
  • Change from baseline in C-Reactive Protein (CRP) concentration [ Time Frame: Baseline and 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651728

Contacts
Contact: Kuntjoro Harimurti, MD +628159792380 kuntjoro.harimurti01@ui.ac.id

Locations
Indonesia
Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, Jakarta, Indonesia, 10340
Contact: Kuntjoro Harimurti, MD     +628159792380     kuntjoro.harimurti01@ui.ac.id    
Principal Investigator: Kuntjoro Harimurti, MD            
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Kuntjoro Harimurti, MD, MSc Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
  More Information

Publications:

Responsible Party: Kuntjoro Harimurti, M.D., M.Sc., Indonesia University
ClinicalTrials.gov Identifier: NCT01651728     History of Changes
Other Study ID Numbers: 48/PT02.FK/ETIK/2012, U1111-1133-2403
Study First Received: July 24, 2012
Last Updated: August 2, 2012
Health Authority: Indonesia: Departement Kesehatan (Department of Health)

Keywords provided by Indonesia University:
Simvastatin
Pneumonia
Elderly
TNF-α
 IFN-ϒ
PAI-1
CRP

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Simvastatin
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013