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Dexamethasone Infusion in Community-acquired Pneumonia (Ovidius)

S

St. Antonius Hospital

Status

Completed

Conditions

Pneumonia

Treatments

Drug: dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT00471640
versie 1

Details and patient eligibility

About

The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

Full description

Community-acquired pneumonia (CAP) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring ICU admission.1 Especially elderly patients may have a severe illness with a high morbidity and mortality rate. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. However, this natural reaction 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. Hypothetically, 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

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 18 to 100 years with a community-acquired pneumonia.

Criteria to determine a community-acquired pneumonia:

  • 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 leukopenia (<4000 cells/mm3)
    • CRP > 15 mg/dl (three times upper limit of normal)

Exclusion criteria

  • o The following groups are excluded:

    • Immunocompromised patients:

      • Patients with a known congenital or achieved 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. (like cyclosporine, cyclofosfamide, azathioprine)
      • Patients with COPD who are on systemic corticosteroids for COPD.
      • Patients who require ICU treatment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
dexamethasone
Treatment:
Drug: dexamethasone
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: dexamethasone

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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