NCT01743755

Santeon-CAP; Dexamethasone in Community-acquired Pneumonia

Santeon-CAP; Dexamethasone in Community-acquired Pneumonia.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study is designed to investigate the beneficial effects of adjunctive dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally aiming at assessing what patients benefit from dexamethasone treatment mostly. A large multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with placebo in 600 patients and with predefined subgroup analyses planned.

Detailed description

Community-acquired pneumonia (CAP) is a common infection. Approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring intensive care unit (ICU) admission. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a mechanism by which invading pathogens are eliminated. However, this reaction of the innate immune system can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung. Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Theoretically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Dexamethasone	Dexamethasone tablet 6 mg, once daily for four consecutive days
DRUG	Placebo	Placebo tablet, once daily for four consecutive days

Timeline

• Start date: 2012-12-01
• Primary completion: 2018-07-13
• Completion: 2018-09-13
• First posted: 2012-12-06
• Last updated: 2019-04-18

Locations

4 sites across 1 country: Netherlands