Simvastatin in community-acquired pneumonia
| ISRCTN | ISRCTN91327214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91327214 |
| Protocol serial number | FIS 070864 |
| Sponsor | The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) |
| Funder | The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) |
- Submission date
- 05/02/2009
- Registration date
- 10/02/2009
- Last edited
- 13/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Infectious Disease Department
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
| Phone | +34 93 26 07 625 |
|---|---|
| jcarratala@ub.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Simvastatin in community-acquired pneumonia requiring hospitalisation: a randomised, double-blind, placebo-controlled trial |
| Study objectives | Simvastatin would be effective and safe to reduce time to clinical stability in patients with community-acquired pneumonia (CAP) requiring hospitalisation. As of 03/02/2010 this record has been updated to reflect a change to the anticipated start and end dates of this trial; the initial trial dates were as follows: Initial anticipated start date: 01/03/2009 Initial anticipated end date: 31/03/2011 |
| Ethics approval(s) | Ethics Committee of the Hospital Universitari de Bellvitge (Comité Ètic d'Investigació Clínica) gave approval on 11th December 2008 (ref: AC099/08) |
| Health condition(s) or problem(s) studied | Community-acquired pneumonia |
| Intervention | 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 total of 4 days. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Simvastatin |
| Primary outcome measure(s) |
Time to clinical stability. Clinical stability will be measured daily during hospitalisation. |
| Key secondary outcome measure(s) |
Determined at presentation in the Emergency Department before receiving simvastatin or placebo, and 48 hours after treatment administration: |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 376 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
08907
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/01/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
