Corticoids in Severe Community-Acquired Pneumonia (CAP)
1 other identifier
interventional
120
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2004
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 26, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 20, 2013
March 1, 2013
8.1 years
May 26, 2009
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of non-response to empiric antimicrobial treatment
5 days
Study Arms (2)
methylprednisolone
EXPERIMENTALmethylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
Placebo
PLACEBO COMPARATORInterventions
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
Eligibility Criteria
You may qualify if:
- Severe community-acquired pneumonia Fine V
- CRP \>=15 mg/100 mL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Servei Pneumologia. Hospital Clinic
Barcelona, Catalonia, 08036, Spain
Servei Pneumoloiga. Hospital Clinic
Barcelona, Catalonia, 08036, Spain
Hospital Clinic
Barcelona, 08036, Spain
Related Publications (2)
Ceccato A, Cilloniz C, Ranzani OT, Menendez R, Agusti C, Gabarrus A, Ferrer M, Sibila O, Niederman MS, Torres A. Treatment with macrolides and glucocorticosteroids in severe community-acquired pneumonia: A post-hoc exploratory analysis of a randomized controlled trial. PLoS One. 2017 Jun 15;12(6):e0178022. doi: 10.1371/journal.pone.0178022. eCollection 2017.
PMID: 28617807DERIVEDTorres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrus A, Sellares J, Restrepo MI, Anzueto A, Niederman MS, Agusti C. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):677-86. doi: 10.1001/jama.2015.88.
PMID: 25688779DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Agusti, MD
Hospital Clinic, Barcelona,Spain.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultor Senior
Study Record Dates
First Submitted
May 26, 2009
First Posted
May 27, 2009
Study Start
January 1, 2004
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
March 20, 2013
Record last verified: 2013-03