Corticoids in Severe Community-acquired Pneumonia
Overview
- Phase
- Phase 4
- Intervention
- methylprednisolone
- Conditions
- Community-Acquired Pneumonia
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Rate of non-response to empiric antimicrobial treatment
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Carlos Agusti
Consultor Senior
Hospital Clinic of Barcelona
Eligibility Criteria
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
Arms & Interventions
methylprednisolone
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
Intervention: methylprednisolone
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Rate of non-response to empiric antimicrobial treatment
Time Frame: 5 days