Community-acquired pneumonia Infections and Infestations Viral pneumonia, not elsewhere classified
Conditions
Interventions
Patients will be randomly assigned to receive simvastatin (20 mg/day) or placebo, that will be orally administered before the antibiotics in the Emergency Department and once daily thereafter for a to
Sponsors
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical stability. Clinical stability will be measured daily during hospitalisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determined at presentation in the Emergency Department before receiving simvastatin or placebo, and 48 hours after treatment administration: 1. Partial pressure of oxygen in the arterial blood (PaO2)/fraction of inspired oxygen (FiO2) 2. C-reactive protein 3. Tumour necrosis factor 4. Interleukin-6 5. Interleukin-10 6. Procalcitonin Recorded from randomisation to 30 days (except in-hospital complications): 7. Need for intensive care unit (ICU) admission 8. Need for mechanical ventilation 9. In-hospital complications, measured throughout period of hospitalisation 10. Readmission (less than 30 days) 11. Early case-fatality rate (less than 48 hours) 12. Overall case-fatality rate (less than 30 days) | — |
Countries
Spain
Outcome results
None listed