Corticoids in Severe Community-Acquired Pneumonia (CAP)

Community-Acquired Pneumonia Clinical Trial

Official title:

Corticoids in Severe Community-acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908713
• Other study ID #: FIS 2003-CA
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2009
• Last updated: March 19, 2013
• Start date: January 2004
• Est. completion date: March 2012

Study information

• Verified date: March 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• methylprednisolone
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
• Placebo
Sodium chloride 0.9% 10 mL every 12 h for 5 days

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Servei Pneumologia. Hospital Clinic	Barcelona	Catalunya
Spain	Servei Pneumoloiga. Hospital Clinic	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of non-response to empiric antimicrobial treatment		5 days	No

External Links

•   Link