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Santeon-CAP; Dexamethasone in Community-acquired Pneumonia

S

St. Antonius Hospital

Status and phase

Terminated
Phase 4

Conditions

Community-acquired Pneumonia

Treatments

Drug: Dexamethasone
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01743755
2011-004566-14 (EudraCT Number)
Santeon-CAP

Details and patient eligibility

About

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.

Full 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).

Enrollment

413 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years or older
  • Chest radiograph showing new opacities.

In combination with two of the following findings:

  • Cough
  • Production of sputum
  • Temp >38,0 °C or <36,0 °C
  • Audible abnormalities by chest examination compatible with pneumonia
  • Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leucopenia (<4000 cells/mm3)
  • C-reactive protein > 15 mg/l (three fold higher than the upper limit of normal)

Exclusion criteria

  • Immunocompromised patients:
  • Patients with a known congenital or acquired immunodeficiency.
  • Patients who received chemotherapy less than 6 weeks ago.
  • Patients who received corticosteroids in the last 6 weeks.
  • Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine).
  • Patients with chronic obstructive pulmonary disease who are on systemic corticosteroids.
  • Patients who require intensive care unit treatment.
  • Patients with tropical worm infection.
  • Patients with dexamethasone intolerance.
  • Pregnant and breastfeeding women.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

413 participants in 2 patient groups, including a placebo group

Dexamethasone
Active Comparator group
Treatment:
Drug: Dexamethasone
Placebo
Placebo Comparator group
Description:
Placebo tablet, once daily for four consecutive days
Treatment:
Drug: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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