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
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Sponsor:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Carlos Agusti, Hospital Clinic of Barcelona
Tracking Information | ||||
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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 |
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 |
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Condition ICMJE | Community-Acquired Pneumonia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | |||
Current Responsible Party | Carlos Agusti, Hospital Clinic of Barcelona | |||
Original Responsible Party | Carlos Agusti, Hospital Clinic, Barcelona, Spain. | |||
Current Study Sponsor ICMJE | Hospital Clinic of Barcelona | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |