NCT00908713

Corticoids in Severe Community-Acquired Pneumonia (CAP)

Corticoids in Severe Community-acquired Pneumonia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Community acquired pneumonia (CAP) is associated with a local and systemic inflammatory response conducted by different pro and counter inflammatory cytokines. The evolution of the infection is mainly dependent on the intensity of the inflammatory response. The AIM of the project is to determine the clinical usefulness of methylprednisolone treatment (0,5 mg/ Kg weight every 12h for 5 days in patients with severe CAP and an excessive inflammatory response( patients identified based on a cut-off point of the reactive C protein (RCP) of 15 mg/dl). A randomized double blind placebo controlled study with two arms will be performed: The study group (patients with excessive inflammatory response) will receive methylprednisolone + antibiotics. Control group will receive placebo + antibiotics. Patients older than 18 years with Fine V pneumonia will be recruited. Clinical data and prognostic factors (APACHE II and, SOFA scores, etiology, mortality at ICU and at 28 days) will be collected.

Conditions

• Community-Acquired Pneumonia

Interventions

Type	Name	Description
DRUG	methylprednisolone	methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
DRUG	Placebo	Sodium chloride 0.9% 10 mL every 12 h for 5 days

Timeline

• Start date: 2004-01-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2009-05-27
• Last updated: 2013-03-20

Locations

3 sites across 1 country: Spain