Corticoids in Severe Community-Acquired Pneumonia (CAP)

Phase 4

Completed

• Conditions: Community-Acquired Pneumonia
• Interventions: Drug: Placebo; Drug: methylprednisolone

• Registration Number: NCT00908713
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Severe community-acquired pneumonia Fine V
• CRP >=15 mg/100 mL

Exclusion Criteria

• Major contraindications for corticosteroids, such as uncontrolled diabetes, immunosuppression
• Previous glucocorticoid treatment during the previous month
• Documented extrapulmonary infection
• Previous hospitalization in the previous month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
methylprednisolone	methylprednisolone	methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days

Primary Outcome Measures

Name	Time	Method
Rate of non-response to empiric antimicrobial treatment	5 days

Trial Locations

Locations (3)

Servei Pneumoloiga. Hospital Clinic; 🇪🇸 Barcelona, Catalunya, Spain

Servei Pneumologia. Hospital Clinic; 🇪🇸 Barcelona, Catalunya, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain