Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

NCT ID: NCT01651728

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Community-Acquired Pneumonia

Keywords

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Simvastatin Pneumonia Elderly TNF-α IFN-ϒ PAI-1 CRP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Simvastatin

Tablet 20 mg once daily for 30 days

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Tablet 20 mg once daily for 30 days

Placebo

Placebo tablet once daily for 30 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

daily for 30 days

Interventions

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Simvastatin

Tablet 20 mg once daily for 30 days

Intervention Type DRUG

Placebo

daily for 30 days

Intervention Type DRUG

Other Intervention Names

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CAS Number 79902-63-9 ATC Code C10AA01

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Kuntjoro Harimurti

M.D., M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuntjoro Harimurti, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia

Locations

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Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Kuntjoro Harimurti, MD

Role: CONTACT

Phone: +628159792380

Email: [email protected]

Facility Contacts

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Kuntjoro Harimurti, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19531550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18955636 (View on PubMed)

Other Identifiers

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U1111-1133-2403

Identifier Type: REGISTRY

Identifier Source: secondary_id

48/PT02.FK/ETIK/2012

Identifier Type: -

Identifier Source: org_study_id