Community-Acquired PneumoniaPhase 3NCT01651728
Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
A Phase 3 study testing Simvastatin in people with Community-Acquired Pneumonia, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Community-Acquired Pneumonia
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2012to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients with pneumonia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10340
Kuntjoro Harimurti, MD, +628159792380, kuntjoro.harimurti01@ui.ac.id
Kuntjoro Harimurti, MD
About this study
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
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.
Read the 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.
- Conditions
- Community-Acquired Pneumonia
- Being tested
- Simvastatin, Placebo
- Keywords
- Simvastatin, Pneumonia, Elderly, TNF-α, IFN-ϒ, PAI-1, CRP
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called CAS Number 79902-63-9, ATC Code C10AA01
Tablet 20 mg once daily for 30 days
PlaceboDrug
daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Tablet 20 mg once daily for 30 days Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | Placebo tablet once daily for 30 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 30 days
Secondary outcomes (4)
Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration
Measured: Baseline and 7 days
Change from baseline in Interferon-gamma (INF-ϒ) concentration
Measured: Baseline and 7 days
Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration
Measured: Baseline and 7 days
Change from baseline in C-Reactive Protein (CRP) concentration
Measured: Baseline and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuntjoro Harimurti, Universitas Indonesia
- Investigators
- Kuntjoro Harimurti, MD, MSc, Principal investigator, Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651728
- Sponsor's protocol ID
- 48/PT02.FK/ETIK/2012
- Other IDs
- U1111-1133-2403
- Status last verified
- Aug 2012
- First submitted
- 24 Jul 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19531550Thomsen 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.
PubMed 18955636
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01651728
- Acronym / sponsor ID
- 48/PT02.FK/ETIK/2012
- Conditions
- Community-Acquired Pneumonia
- Keywords
- Simvastatin, Pneumonia, Elderly, TNF-α, IFN-ϒ, PAI-1, CRP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinTablet 20 mg once daily for 30 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet once daily for 30 days |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly patients with pneumonia
Key exclusion criteria (7 listed)
- Severe septic condition
- Hepatic Cirrhosis
- Acute coronary disease
- Total cholesterol which is too high or too low
- In anticoagulant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinAlso: CAS Number 79902-63-9, ATC Code C10AA01Tablet 20 mg once daily for 30 days | Drug | Simvastatin |
| Placebodaily for 30 days | Drug | Placebo |
Primary outcome
Death
Time frame: 30 days
4 secondary outcomes
Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration
Time frame: Baseline and 7 days
Change from baseline in Interferon-gamma (INF-ϒ) concentration
Time frame: Baseline and 7 days
Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration
Time frame: Baseline and 7 days
Change from baseline in C-Reactive Protein (CRP) concentration
Time frame: Baseline and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Background: PubMed 19531550Dublin 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.
- Background: PubMed 18955636Thomsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuntjoro Harimurti, MD, MSc principal investigator
Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simvastatin in people with Community-Acquired Pneumonia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuntjoro Harimurti, MD (+628159792380, kuntjoro.harimurti01@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651728, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.