Corticoids in Severe Community-Acquired Pneumonia (CAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Agusti, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00908713
First received: May 26, 2009
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Community-Acquired Pneumonia
Drug: methylprednisolone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticoids in Severe Community-acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Rate of non-response to empiric antimicrobial treatment [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2004
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methylprednisolone
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
Drug: methylprednisolone
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
Other Name: solumoderin
Placebo Comparator: Placebo Drug: Placebo
Sodium chloride 0.9% 10 mL every 12 h for 5 days
Other Name: sodium chloride

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908713

Locations
Spain
Servei Pneumoloiga. Hospital Clinic
Barcelona, Catalunya, Spain, 08036
Servei Pneumologia. Hospital Clinic
Barcelona, Catalunya, Spain, 08036
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Carlos Agusti, MD Hospital Clinic, Barcelona,Spain.
  More Information

Additional Information:
No publications provided

Responsible Party: Carlos Agusti, Consultor Senior, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00908713     History of Changes
Other Study ID Numbers: FIS 2003-CA
Study First Received: May 26, 2009
Last Updated: March 19, 2013
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Hospital Clinic of Barcelona:
Severe CAP
Adjuvant therapy
Glucocorticoids
CAP Fine V with C-reactive protein >= 15 mg/100 mL

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014