Condition category
Infections and Infestations
Date applied
05/02/2009
Date assigned
10/02/2009
Last edited
13/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.isciii.es

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

Publication citations

Additional files

Editorial Notes