Corticoids in Severe Community-Acquired Pneumonia (CAP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2012-03-31

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.

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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.

Conditions

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Community-Acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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methylprednisolone

methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type DRUG

methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sodium chloride 0.9% 10 mL every 12 h for 5 days

Interventions

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methylprednisolone

methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days

Intervention Type DRUG

Placebo

Sodium chloride 0.9% 10 mL every 12 h for 5 days

Intervention Type DRUG

Other Intervention Names

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solumoderin sodium chloride

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No