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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00471640 |
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Date of registration:
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08/05/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dexamethasone Infusion in Community-acquired Pneumonia
Ovidius |
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Scientific title:
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Dexamethasone Infusion in Community-acquired Pneumonia |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00471640 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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D Biesma, dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Antonius Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pneumonia
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Intervention(s)
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Drug: dexamethasone
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Primary Outcome(s)
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length of hospital stay
[Time Frame: 30 days]
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Secondary Outcome(s)
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side-effects inflammation markers lung function
[Time Frame: 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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