Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
Primary Purpose
Community-Acquired Pneumonia
Status
Unknown status
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Community-Acquired Pneumonia focused on measuring Simvastatin, Pneumonia, Elderly, TNF-α, IFN-ϒ, PAI-1, CRP
Eligibility 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
Sites / Locations
- Cipto Mangunkusumo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Simvastatin
Placebo
Arm Description
Tablet 20 mg once daily for 30 days
Placebo tablet once daily for 30 days
Outcomes
Primary Outcome Measures
Death
Secondary Outcome Measures
Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration
Change from baseline in Interferon-gamma (INF-ϒ) concentration
Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration
Change from baseline in C-Reactive Protein (CRP) concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01651728
Brief Title
Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Pneumonia
Keywords
Simvastatin, Pneumonia, Elderly, TNF-α, IFN-ϒ, PAI-1, CRP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Tablet 20 mg once daily for 30 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet once daily for 30 days
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
CAS Number 79902-63-9, ATC Code C10AA01
Intervention Description
Tablet 20 mg once daily for 30 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
daily for 30 days
Primary Outcome Measure Information:
Title
Death
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration
Time Frame
Baseline and 7 days
Title
Change from baseline in Interferon-gamma (INF-ϒ) concentration
Time Frame
Baseline and 7 days
Title
Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration
Time Frame
Baseline and 7 days
Title
Change from baseline in C-Reactive Protein (CRP) concentration
Time Frame
Baseline and 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuntjoro Harimurti, MD
Phone
+628159792380
Email
kuntjoro.harimurti01@ui.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuntjoro Harimurti, MD, MSc
Organizational Affiliation
Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10340
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuntjoro Harimurti, MD
Phone
+628159792380
Email
kuntjoro.harimurti01@ui.ac.id
First Name & Middle Initial & Last Name & Degree
Kuntjoro Harimurti, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19531550
Citation
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.
Results Reference
background
PubMed Identifier
18955636
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
We'll reach out to this number within 24 hrs