drugset / Trial / NCT00908713

Corticoids in Severe Community-Acquired Pneumonia (CAP)

NCT00908713 ↗

Phase 4 Completed 120 enrolled Hospital Clinic of Barcelona
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.

Timeline

Start
2004-01
Primary completion
2012-02
Completion
2012-03

Outcome

Met primary endpoint

paper There was less treatment failure among patients from the methylprednisolone group (8 patients [13%]) compared with the placebo group (18 patients [31%]) (P = .02) PMID 25688779 ↗

paper Corticosteroid treatment reduced the risk of treatment failure (odds ratio, 0.34 [95% CI, 0.14 to 0.87]; P = .02). PMID 25688779 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 0.5 mg/kg Intravenous

Indications