Contact information
Type
Scientific
Primary contact
Prof Jordi Carratalà
ORCID ID
Contact details
Infectious Disease Department
Hospital Universitari de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
+34 93 26 07 625
jcarratala@ub.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FIS 070864
Study information
Scientific title
Simvastatin in community-acquired pneumonia requiring hospitalisation: a randomised, double-blind, placebo-controlled trial
Acronym
Study hypothesis
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
Ethics Committee of the Hospital Universitari de Bellvitge (Comité Ètic d'Investigació Clínica) gave approval on 11th December 2008 (ref: AC099/08)
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Simvastatin
Primary outcome measures
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 trial start date
01/12/2009
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
376
Participant 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
Recruitment start date
01/12/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Infectious Disease Department
Barcelona
08907
Spain
Sponsor information
Organisation
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Sponsor details
Sinesio Delagado 4
Madrid
28029
Spain
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25564143