Community Acquired PneumoniaPhase 4NCT00946166
Impact of Statins on Cytokine Expression in Pneumonia
A Phase 4 study testing simvastatin in people with Community Acquired Pneumonia and Cardiovascular Risk Factors, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia, Cardiovascular Risk Factors
- What is being tested?
- simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age,
- Chart documentation by a clinician of an initial working diagnosis of pneumonia within 24 hours of admission,
- Chest x-ray or other imaging evidence consistent with pneumonia within 48 hours of hospitalization, and
- One of the following severity criteria: pneumonia severity index class III or higher, at least 2/5 components of the CURB-65, or ICU level care within 24 hours of admission.
- Having one Food and Drug Agency approved indication for statin therapy
Who cannot join
- Prior Treatment with one or more doses of a statin within 30-days prior to admission or during the current hospitalization.
- Hospitalization > 24 hours at time of the diagnosis of pneumonia.
- Hospitalization > 48 hours at time of study enrollment.
- Residence in a skilled nursing facility.
- Previously diagnosed human immunodeficiency virus infection with a current CD4 count < 200 cells/mm.
- Immunosuppression
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- Patient or family decision to limit medical care ("comfort measures only").
- Known allergy to statin therapy.
- Active or planned pregnancy or breastfeeding.
- Inability to take oral medications at the time of study enrollment.
- Pre-existing liver disease or AST/ALT > 10% the upper limit of normal.
- Creatinine phosphokinase (CPK or CK) > 50% above the upper limit of normal.
- Partial ileal bypass.
- Concurrent treatment with potential interacting drugs: ketoconazole, itraconazole, amiodarone, clarithromycin, erythromycin, cyclosporine, danazol, niacin, protease inhibitors, telithromycin, verapamil, gemfiborzil, ezetimibe (Zetia), nefazodone.
- Transfer from an outside hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, 78229
About this study
The investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have pneumonia. The people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. Some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. The study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.
- Being tested
- simvastatin, Placebo
- Keywords
- pneumonia, statins, cytokines
- 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
40 mg daily in the evening for a maximum of 14 days
PlaceboDrug
Simvastatin-like placebo administered daily in the evening for a maximum of 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Subjects receive standard treatment for pneumonia and a simvastatin-like placebo Receives: Drug: Placebo |
| Simvastatin | Experimental | Subjects receive simvastatin in addition to standard pneumonia treatment Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels
Measured: enrollment, 24h, 48h, 72h, hospital discharge
Secondary outcomes (1)
30-day mortality
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Investigator left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric M Mortensen, MD, Principal investigator, University of Texas Health Science Center/ South Texas Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946166
- Sponsor's protocol ID
- HSC2009-183H
- Status last verified
- Apr 2015
- First submitted
- 22 Jul 2009
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Statins on Cytokine Expression in Pneumonia
- ClinicalTrials.gov ID
- NCT00946166
- Acronym / sponsor ID
- HSC2009-183H
- Keywords
- pneumonia, statins, cytokines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 Jul 2009 (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 investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have pneumonia. The people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. Some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. The study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Drug: PlaceboSubjects receive standard treatment for pneumonia and a simvastatin-like placebo |
| Simvastatin | Experimental | Drug: simvastatinSubjects receive simvastatin in addition to standard pneumonia treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age,
- Chart documentation by a clinician of an initial working diagnosis of pneumonia within 24 hours of admission,
- Chest x-ray or other imaging evidence consistent with pneumonia within 48 hours of hospitalization, and
- One of the following severity criteria: pneumonia severity index class III or higher, at least 2/5 components of the CURB-65, or ICU level care within 24 hours of admission.
- Having one Food and Drug Agency approved indication for statin therapy
Key exclusion criteria (15 listed)
- Prior Treatment with one or more doses of a statin within 30-days prior to admission or during the current hospitalization.
- Hospitalization > 24 hours at time of the diagnosis of pneumonia.
- Hospitalization > 48 hours at time of study enrollment.
- Residence in a skilled nursing facility.
- Previously diagnosed human immunodeficiency virus infection with a current CD4 count < 200 cells/mm.
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 |
|---|---|---|
| simvastatin40 mg daily in the evening for a maximum of 14 days | Drug | Simvastatin |
| PlaceboSimvastatin-like placebo administered daily in the evening for a maximum of 14 days | Drug | Placebo Control |
Primary outcome
Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels
Time frame: enrollment, 24h, 48h, 72h, hospital discharge
1 secondary outcome
30-day mortality
Time frame: 30-days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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.
Eric M Mortensen, MD principal investigator
University of Texas Health Science Center/ South Texas Veterans Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing simvastatin in people with Community Acquired Pneumonia and Cardiovascular Risk Factors, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels (time frame: enrollment, 24h, 48h, 72h, hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2015.