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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22426306
Enrollment
56
Registered
2005-10-05
Start date
2000-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe community-acquired pneumonia Respiratory Pneumonia

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 m

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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: Exclusion criteria included: 1. Age 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026