Clinical trial NCT00908713: Corticoids in Severe Community-Acquired Pneumonia (CAP)
Official title: Corticoids in Severe Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community-Acquired Pneumonia
Keywords: Severe CAP
Adjuvant therapy
Glucocorticoids
CAP Fine V with C-reactive protein >= 15 mg/100 mL
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2009-05-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of non-response to empiric antimicrobial treatment
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Servei Pneumologia. Hospital Clinic
state: Catalunya
city: Barcelona
country: Spain
facility: Servei Pneumoloiga. Hospital Clinic
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic, Barcelona,Spain.
name: Carlos Agusti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Torres 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.