Corticoids in Severe Community-Acquired Pneumonia (CAP)

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

Tracking Information

• First Submitted Date: May 26, 2009
• First Posted Date: May 27, 2009
• Last Update Posted Date: March 20, 2013
• Study Start Date: January 2004
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 26, 2009): Rate of non-response to empiric antimicrobial treatment [ Time Frame: 5 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Corticoids in Severe Community-Acquired Pneumonia (CAP)
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Community-Acquired Pneumonia

Intervention

• 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

• 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 *

• 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.
• Torres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrús A, Sellarés J, Restrepo MI, Anzueto A, Niederman MS, Agustí 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 26, 2009): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT00908713
• Other Study ID Numbers: FIS 2003-CA
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Carlos Agusti, Hospital Clinic of Barcelona
• Original Responsible Party: Carlos Agusti, Hospital Clinic, Barcelona, Spain.
• Current Study Sponsor: Hospital Clinic of Barcelona
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Carlos Agusti, MD; Hospital Clinic, Barcelona,Spain.

• PRS Account: Hospital Clinic of Barcelona
• Verification Date: March 2013