Simvastatin in community-acquired pneumonia
Completed
- Conditions
- Community-acquired pneumoniaInfections and InfestationsViral pneumonia, not elsewhere classified
- Registration Number
- ISRCTN91327214
- Lead Sponsor
- The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 376
Inclusion Criteria
1. Immunocompetent adults (aged greater than 18 years, either sex)
2. Received a diagnosis of community-acquired pneumonia in the Emergency Department
3. Admitted to the hospital
Exclusion Criteria
1. Absence of written informed consent
2. Severe immunosuppression
3. Pregnancy
4. Not able to drink and eat
5. Prior statin therapy
6. Treatment with any of the following drugs: azoles, macrolides, amiodarone, antidepressant drugs and calcium channel blockers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to clinical stability. Clinical stability will be measured daily during hospitalisation.
- Secondary Outcome Measures
Name Time Method Determined at presentation in the Emergency Department before receiving simvastatin or placebo, and 48 hours after treatment administration:<br>1. Partial pressure of oxygen in the arterial blood (PaO2)/fraction of inspired oxygen (FiO2)<br>2. C-reactive protein<br>3. Tumour necrosis factor<br>4. Interleukin-6<br>5. Interleukin-10<br>6. Procalcitonin<br><br>Recorded from randomisation to 30 days (except in-hospital complications):<br>7. Need for intensive care unit (ICU) admission<br>8. Need for mechanical ventilation<br>9. In-hospital complications, measured throughout period of hospitalisation<br>10. Readmission (less than 30 days)<br>11. Early case-fatality rate (less than 48 hours)<br>12. Overall case-fatality rate (less than 30 days)