Dexamethasone in community-acquired pneumonia.

Phase 1

• Conditions: Patients with a community-acquired pneumonia who are admitted to the hospital.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-004566-14-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

Patients aged 18 to 100 years with a community-acquired pneumonia which requires admission.
Criteria to determine a community-acquired pneumonia:
-Chest radiograph showing new opacities.
In combination with two of the following findings:
0Cough
0Production of sputum
0Temp >38,0 °C or <36,0 °C
0Audible abnormalities by chest examination compatible with pneumonia
0Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leucopenia (<4000 cells/mm3)
0CRP > 15 mg/l (three fold higher than the upper limit of normal)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

-Immunocompromised patients:
0Patients with a known congenital or acquired immunodeficiency.
0Patients who received chemotherapy less than 6 weeks ago.
0Patients who received corticosteroids in the last 6 weeks.
0Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine).
0Patients with COPD who are on systemic corticosteroids for COPD.
-Patients who require ICU treatment.
-Patients with tropical worm infection.
-Patients with dexamethasone intolerance.
-Pregnant and breastfeeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The effect of dexamethasone on clinical outcome in patients admitted with CAP;<br> Primary end point(s): Length of hospital stay.<br><br> ;Timepoint(s) of evaluation of this end point: When all 600 patients are included.;<br> Secondary Objective: Study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis based on:<br> odisease severity score (PSI 1-3 vs. PSI 4-5);<br> oCRP level at admission;<br> ocausative microorganism (Pneumococcus antigentest positive vs. negative);<br> ocytokine response (IL-6 and IL-10) over time;<br> ocortisol level over time;<br> oprocalcitonin over time.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): -in-hospital mortality<br> -one-year mortality<br> ;Timepoint(s) of evaluation of this end point: When all 600 patients are included.