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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):

Study Description
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.

Condition or disease Intervention/treatment Phase
Community-Acquired Pneumonia Drug: methylprednisolone Drug: Placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticoids in Severe Community-acquired Pneumonia
Study Start Date : January 2004
Primary Completion Date : February 2012
Study Completion Date : March 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Rate of non-response to empiric antimicrobial treatment [ Time Frame: 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908713


Locations
Spain
Servei Pneumologia. Hospital Clinic
Barcelona, Catalunya, Spain, 08036
Servei Pneumoloiga. 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos Agusti, Consultor Senior, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00908713     History of Changes
Other Study ID Numbers: FIS 2003-CA
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Carlos Agusti, 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
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents