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Dexamethasone Infusion in Community-acquired Pneumonia (Ovidius)

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
dexamethasone
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring pneumonia, dexamethasone, community-acquired pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gelderse Vallei Ede
  • St Antonius Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

dexamethasone

Placebo

Outcomes

Primary Outcome Measures

length of hospital stay

Secondary Outcome Measures

side-effects inflammation markers lung function

Full Information

First Posted
May 8, 2007
Last Updated
September 24, 2010
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00471640
Brief Title
Dexamethasone Infusion in Community-acquired Pneumonia
Acronym
Ovidius
Official Title
Dexamethasone Infusion in Community-acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Antonius Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
pneumonia, dexamethasone, community-acquired pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
dexamethasone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
4 days 5 mg
Primary Outcome Measure Information:
Title
length of hospital stay
Time Frame
30 days
Secondary Outcome Measure Information:
Title
side-effects inflammation markers lung function
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D Biesma, dr.
Organizational Affiliation
St. Antonius Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gelderse Vallei Ede
City
Ede
State/Province
Gelderland
Country
Netherlands
Facility Name
St Antonius Hosptial
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3430 EM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27317257
Citation
Raeven VM, Spoorenberg SM, Boersma WG, van de Garde EM, Cannegieter SC, Voorn GP, Bos WJ, van Steenbergen JE; Alkmaar study group; Ovidius study group. Atypical aetiology in patients hospitalised with community-acquired pneumonia is associated with age, gender and season; a data-analysis on four Dutch cohorts. BMC Infect Dis. 2016 Jun 17;16:299. doi: 10.1186/s12879-016-1641-9.
Results Reference
derived
PubMed Identifier
22942205
Citation
Remmelts HH, van de Garde EM, Meijvis SC, Peelen EL, Damoiseaux JG, Grutters JC, Biesma DH, Bos WJ, Rijkers GT. Addition of vitamin D status to prognostic scores improves the prediction of outcome in community-acquired pneumonia. Clin Infect Dis. 2012 Dec;55(11):1488-94. doi: 10.1093/cid/cis751. Epub 2012 Aug 31.
Results Reference
derived
PubMed Identifier
21636122
Citation
Meijvis SC, Hardeman H, Remmelts HH, Heijligenberg R, Rijkers GT, van Velzen-Blad H, Voorn GP, van de Garde EM, Endeman H, Grutters JC, Bos WJ, Biesma DH. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.
Results Reference
derived

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Dexamethasone Infusion in Community-acquired Pneumonia

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