Corticoids in Severe Community-Acquired Pneumonia (CAP)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Corticoids in Severe Community-acquired Pneumonia

Conditions
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Community-Acquired Pneumonia

Intervention / Treatment
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* Drug: methylprednisolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylprednisolone<br>methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days | Drug: methylprednisolone<br>* methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days<br>* Other names: solumoderin;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sodium chloride 0.9% 10 mL every 12 h for 5 days<br>* Other names: sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of non-response to empiric antimicrobial treatment |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe CAP, Adjuvant therapy, Glucocorticoids, CAP Fine V with C-reactive protein >= 15 mg/100 mL