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Completed

NCT Number: NCT00908713

Corticoids in Severe Community-Acquired Pneumonia (CAP)

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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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Servei Pneumologia. Hospital Clinic, Barcelona, Catalonia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

Other names: solumoderin

Placebo

Drug

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

Other names: sodium chloride

Primary outcomes

  1. Rate of non-response to empiric antimicrobial treatment

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Corticoids in Severe Community-acquired Pneumonia

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
May 27, 2009
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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