Simvastatin in community-acquired pneumonia
| ISRCTN | ISRCTN91327214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91327214 |
| Secondary identifying numbers | FIS 070864 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jordi Carratalà
Scientific
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
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Simvastatin |
| Primary outcome measure | Time to clinical stability. Clinical stability will be measured daily during hospitalisation. |
| Secondary outcome measures | 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) |
| Overall study start date | 01/12/2009 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 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
Infectious Disease Department
Barcelona
08907
Spain
08907
Spain
Sponsor information
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Research organisation
Research organisation
Sinesio Delagado 4
Madrid
28029
Spain
| Website | http://www.isciii.es |
|---|---|
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Research organisation
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
