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Corticoids in Severe Community-Acquired Pneumonia (CAP)

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ClinicalTrials.gov Identifier: NCT00908713
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):
Carlos Agusti, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE May 26, 2009
First Posted Date  ICMJE May 27, 2009
Last Update Posted Date March 20, 2013
Study Start Date  ICMJE January 2004
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2009)
Rate of non-response to empiric antimicrobial treatment [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Corticoids in Severe Community-Acquired Pneumonia (CAP)
Official Title  ICMJE Corticoids in Severe Community-acquired Pneumonia
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Community-Acquired Pneumonia
Intervention  ICMJE
  • Drug: methylprednisolone
    methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
    Other Name: solumoderin
  • Drug: Placebo
    Sodium chloride 0.9% 10 mL every 12 h for 5 days
    Other Name: sodium chloride
Study Arms  ICMJE
  • Experimental: methylprednisolone
    methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
    Intervention: Drug: methylprednisolone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908713
Other Study ID Numbers  ICMJE FIS 2003-CA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlos Agusti, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos Agusti, MD Hospital Clinic, Barcelona,Spain.
PRS Account Hospital Clinic of Barcelona
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP