Condition category
Respiratory
Date applied
03/08/2005
Date assigned
05/10/2005
Last edited
09/07/2012
Prospective/Retrospective
Retrospectively 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

Dr Jordi Dorca

ORCID ID

Contact details

Servei de Pneumologia
Hospital de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
+34 3 260 76 85
jodorca@csub.scs.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FIS Grant 99/0838 and AEM 99/0145

Study information

Scientific title

Acronym

Study hypothesis

In our study we try to demonstrate if a corticosteroid adjuvant therapy (CAT), consisting of a bolus of methylprednisolone (MPDN) given prior to antibiotic treatment followed by a sustained infusion for 9 days, modulates the inflamatory response and improves the clinical outcome of CAP presenting with respiratory failure and extensive radiological changes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Severe community-acquired pneumonia

Intervention

All patients received intravenous antibiotic treatment consisting of 1 g per day of ceftriaxone and 500 mg/day of levofloxacin. In addition, a bolus of 200 mg of MPDN or placebo was administered, 30 minutes before starting the antibiotic treatment. Thereafter, a maintenance intravenous dose (20 mg/6 hours) was given for three days, then 20 mg/12 hours for three days, and finally 20 mg/day for another three days.

Intervention type

Drug

Phase

Not Specified

Drug names

Methylprednisolone

Primary outcome measures

The presence of respiratory failure needing conventional mechanical ventilation (MV) or non-invasive positive pressure ventilation (NNPV), was selected as primary outcome of the study.

Secondary outcome measures

1. Eventual differences in relation to other main variables relative to the outcome, such as days in hospital, need and duration of intensive care unit (ICU) stay and mortality
2. Differences in the inflammatory response measured in venous blood

Overall trial start date

01/01/2000

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Community-acquired pneumonia (CAP) presenting extensive radiographic consolidations (affecting entirely at least two lobes), and respiratory failure (pO2/FiO2 <300).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56

Participant exclusion criteria

Exclusion criteria included:
1. Age <18 years and >75 years
2. No written informed consent available
3. Known hypersensitivity to steroids
4. Steroid treatment in the previous 48 hours
5. Need of steroid treatment for any reason (asthma, chronic obstructive pulmonary disease [COPD] etc.)
6. Uncontrolled diabetes mellitus
7. Active peptic ulcer
8. Active Mycobacterial or fungal infection
9. Reported severe imunosuppresion
10. Hospital admission during the previous 8 days
11. Empyema
12. Extrapulmonary septic manifestations
13. Presence of shock
14. Need of mechanical ventilation prior to the inclusion into the study

Recruitment start date

01/01/2000

Recruitment end date

31/12/2002

Locations

Countries of recruitment

Spain

Trial participating centre

Servei de Pneumologia
Barcelona
08907
Spain

Sponsor information

Organisation

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)

Sponsor details

C/ sinesio Delgado 4-12
Madrid
28029
Spain
+34 1 387 78 04
fis@isciii.es

Sponsor type

Government

Website

http://www.isciii.es

Funders

Funder type

Government

Funder name

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (FIS grant 99/0838)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Red Respira (Spain) (ref: ISCIII RTIC 03/11)

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21406101

Publication citations

  1. Results

    Fernández-Serrano S, Dorca J, Garcia-Vidal C, Fernández-Sabé N, Carratalà J, Fernández-Agüera A, Corominas M, Padrones S, Gudiol F, Manresa F, Effect of corticosteroids on the clinical course of community-acquired pneumonia: a randomized controlled trial., Crit Care, 2011, 15, 2, R96, doi: 10.1186/cc10103.

Additional files

Editorial Notes