E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035664 |
E.1.2 | Term | Pneumonia |
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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 |
Is there a significant reduction on length of hospital stay in patients with a CAP treated with intravenous dexamethasone? |
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E.2.2 | Secondary objectives of the trial |
What is the effect of intravenous dexamethasone in patients with a CAP on the length of treatment with intravenous antibiotics? What is the effect of intravenous dexamethasone in patients with a CAP on admission to ICU, inflammation markers and health performance? What are the side-effects of three days of intravenous dexamethasone in patients with a CAP? What is the effect of intravenous dexamethasone in patients with a CAP on lung function? Mortality in patients with CAP treated with or without dexamethasone Prognostic value of serum ACE activity on pneumonia outcome Analysis of cost savings and effectiveness of the use of intravenous dexamethasone in patients with a CAP.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Inclusion criteria: o 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: · 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/l (three times upper limit of normal)
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E.4 | Principal exclusion criteria |
- 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. § Pregnant women § Patients with dexamethasone intolerance § Patients with a tropical worm infection
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
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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after inclusion of 300 patients |
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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 | |
E.8.9.1 | In the Member State concerned days | |