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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

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

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01651728

First Posted

July 24, 2012

Last Updated

August 2, 2012

Sponsor

Indonesia University

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

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

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

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

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Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

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