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Effect of corticosteroid adjunctive therapy on the clinical course and outcome of severe community-acquired pneumonia (CAP): a randomised, double-blinded study
ISRCTN ISRCTN22426306
DOI 10.1186/ISRCTN22426306
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of corticosteroid adjunctive therapy on the clinical course and outcome of severe community-acquired pneumonia (CAP): a randomised, double-blinded study
Scientific title
Acronym N/A
Serial number at source FIS Grant 99/0838 and AEM 99/0145
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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Spain
Disease/condition/study domain Severe community-acquired pneumonia
Participants - inclusion criteria Community-acquired pneumonia (CAP) presenting extensive radiographic consolidations (affecting entirely at least two lobes), and respiratory failure (pO2/FiO2 <300).
Participants - 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
Anticipated start date 01/01/2000
Anticipated end date 31/12/2002
Status of trial Completed
Patient information material
Target number of participants 56
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (FIS grant 99/0838)
2. Red Respira (Spain) (ref: ISCIII RTIC 03/11)
Trial website
Publications 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21406101
Contact name Dr  Jordi  Dorca
  Address Servei de Pneumologia
Hospital de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
  City/town Barcelona
  Zip/Postcode 08907
  Country Spain
  Tel +34 3 260 76 85
  Fax +34 3 260 76 39
  Email jodorca@csub.scs.es
Sponsor Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)
  Address C/ sinesio Delgado 4-12
  City/town Madrid
  Zip/Postcode 28029
  Country Spain
  Tel +34 1 387 78 04
  Fax +34 1 387 77 66
  Email fis@isciii.es
  Sponsor website: http://www.isciii.es
Date applied 03/08/2005
Last edited 09/07/2012
Date ISRCTN assigned 05/10/2005
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