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Corticoids in Severe Community-Acquired Pneumonia (CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908713
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Carlos Agusti, 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.

Condition or disease Intervention/treatment Phase
Community-Acquired Pneumonia Drug: methylprednisolone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticoids in Severe Community-acquired Pneumonia
Study Start Date : January 2004
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: methylprednisolone
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
Drug: methylprednisolone
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
Other Name: solumoderin

Placebo Comparator: Placebo Drug: Placebo
Sodium chloride 0.9% 10 mL every 12 h for 5 days
Other Name: sodium chloride

Primary Outcome Measures :
  1. Rate of non-response to empiric antimicrobial treatment [ Time Frame: 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00908713

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Servei Pneumologia. Hospital Clinic
Barcelona, Catalunya, Spain, 08036
Servei Pneumoloiga. Hospital Clinic
Barcelona, Catalunya, Spain, 08036
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Principal Investigator: Carlos Agusti, MD Hospital Clinic, Barcelona,Spain.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Carlos Agusti, Consultor Senior, Hospital Clinic of Barcelona Identifier: NCT00908713    
Other Study ID Numbers: FIS 2003-CA
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013
Keywords provided by Carlos Agusti, Hospital Clinic of Barcelona:
Severe CAP
Adjuvant therapy
CAP Fine V with C-reactive protein >= 15 mg/100 mL
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents