E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Community aquired pneumonia |
|
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 |
To determine if treatment with rosuvastatin can reduce the rate of major cardiovascular events during 6 months in 55-85 years old patients who are hospitilazid for pneumonia. |
|
E.2.2 | Secondary objectives of the trial |
- To determine if the rates of mortality and infectious disease events are correlated to rosuvastatin treatment or not - To determine if treatment with rosuvastatin has an effect on inflammatory parameters (IP) in plasma overe time. The IP parameters are HMGB1, PCT, high-sensitive CRP, IL-6 and other pro-inflammatory cytikines. - To investigate if changes in serum lipids and lipoprotein levels are correlated to major cardiovascular events and number and type of readmission, e.g. infectious or cancer - To determine if treatment with rosuvastatin has an effect on BNP levels in plasma over time - To investigate the prevalence of different airway pathogens in the study population - To investigate the clinical characteristics (demografi, confounders, co-morbidity and CRB-65 (pneumonia severity index) in the study population in relation to mortality
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age 55-85 years old - CAP diagnose - Written informed consent |
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E.4 | Principal exclusion criteria |
- Previous participation in the study - pervious participation in any other clinical trial, within 6 months period - ongoing drug treatment with a statin or any other lipidlowering therapy - co-morbid condition with a life expectancy less than one year - serum ASAT or Serum ALAT>times UNL - serum creatinin kinase (s-CK) > 5 times UNL - serum kreatinin (S-Krea) > 200µkat/L -poorly controlledhypothyroid function - inhereditied myopathia - alcoholdependecy - drug treatment with erytromycin, proteas inhibitors, gemfibrozil, ciklosporin, niacin, fibrates (except fenofibrate) and ezetemib - any other condition after judgement of the investigator would make the patient unsuiteable for enrollment, or could interfere with the study protocol -preganacy or planned pregnancy or breastfeeding - |
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E.5 End points |
E.5.1 | Primary end point(s) |
proportion of patients readmissioned to hospital due to infectious diseases or cardiovascular events |
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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 | 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
| 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 | 5 |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 31 |