E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with a community-acquired pneumonia who are admitted to the hospital. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with a pneumonia which is not acquired in the hospital. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The effect of dexamethasone on clinical outcome in patients admitted with CAP |
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E.2.2 | Secondary objectives of the trial |
Study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis based on: o disease severity score (PSI 1-3 vs. PSI 4-5); o CRP level at admission; o causative microorganism (Pneumococcus antigentest positive vs. negative); o cytokine response (IL-6 and IL-10) over time; o cortisol level over time; o procalcitonin over time.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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: 0 Cough 0 Production of sputum 0 Temp >38,0 °C or <36,0 °C 0 Audible abnormalities by chest examination compatible with pneumonia 0 Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leucopenia (<4000 cells/mm3) 0 CRP > 15 mg/l (three fold higher than the upper limit of normal)
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E.4 | Principal exclusion criteria |
- Immunocompromised patients: 0 Patients with a known congenital or acquired immunodeficiency. 0 Patients who received chemotherapy less than 6 weeks ago. 0 Patients who received corticosteroids in the last 6 weeks. 0 Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine). 0 Patients 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
When all 600 patients are included. |
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E.5.2 | Secondary end point(s) |
- in-hospital mortality - one-year mortality |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
When all 600 patients are included. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |