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Corticoids in Severe Community-Acquired Pneumonia (CAP)

Corticoids in Severe Community-acquired Pneumonia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00908713
Enrollment
120
Registered
2009-05-27
Start date
2004-01-31
Completion date
2012-03-31
Last updated
2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-Acquired Pneumonia

Keywords

Severe CAP, Adjuvant therapy, Glucocorticoids, CAP Fine V with C-reactive protein >= 15 mg/100 mL

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.

Interventions

DRUGmethylprednisolone

methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days

DRUGPlacebo

Sodium chloride 0.9% 10 mL every 12 h for 5 days

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of non-response to empiric antimicrobial treatment5 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026