Effect of corticosteroid adjunctive therapy on the clinical course and outcome of severe community-acquired pneumonia (CAP): a randomised, double-blinded study

Completed

Conditions: Severe community-acquired pneumonia
Respiratory
Pneumonia

Registration Number: ISRCTN22426306

Lead Sponsor: Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 56

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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<br>2. Differences in the inflammatory response measured in venous blood