E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Lung Injury (ALI) - Acute Respiratory Distress Syndrome (ARDS) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049874 |
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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 |
Evaluate the effectiveness of low-dose methilprednisolone infusion compared to placebo, on the incidence of all-cause 28 day mortality, defined as the proportion of patients alive in each group under study day 28 at midnight |
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E.2.2 | Secondary objectives of the trial |
to measure the hospital effects of low-dose methylprednisolone infusion compared to placebo: A. Systemic inflammation Resolution of systemic inflammation, defined as timing to a 50% reduction in Creactive protein level from study entry. 2B. Pulmonary and extra-pulmonary organ disfunction Reduction in duration of mechanical ventilation, defined as (a) mechanical ventilation-free days to day 28, and (b) duration of mechanical ventilation on day 28. Improvement in multiple organ dysfunction syndrome (MODS), defined as MODSfree days to day 28. Reduction in duration of intensive care unit (ICU) stay and hospital stay. Reduction in hospital cardiovascular morbidity-mortality, defined as acute myocardial ischemia-infarction, cerebrovascular accident (stroke), sudden (in the absence of vasopressor-dependent shock) cardiac event or death as a result of ventricular arrhythmia, myocardial ischemia-infarction, or stroke B. Complications |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Age. Patients age 18 years or older admitted to the intensive care unit. 2. ALI/ARDS criteria. The diagnosis of ALI/ARDS requires all of the following criteria: Respiratory failure requiring mechanical ventilation via endotracheal intubation or noninvasive positive pressure ventilation Acute onset of bilateral pulmonary densities on chest radiograph in the contest of appropriate predisposing injury or illness with no evidence of left ventricular failure, Static pulmonary compliance < 50 cm H2O Ratio of partial pressure of arterial oxygen to partial pressure of alveolar oxygen (PaO2:FiO2 ) equal or less than 300 (criteria for ALI) or 200 (criteria for ARDS)with FiO2 1.0. 3. Severe ARDS. PaO2:FiO2 equal or less than 200 after 30 minutes of standardized ventilatory management on PEEP of 10 cm H2O with FiO2 1.0. |
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E.4 | Principal exclusion criteria |
Failure to obtain written informed consent;trauma-induced ARDS;major gastrointestinal bleeding requiring transfusion of 5 units or more of packed red blood cells (PRBC) within 3 months current hospitalization;condition requiring > 0.5mg/Kg/day of prednisone equivalent (i.e., acute asthma or chronic obstructive pulmonary disease [COPD]);patients enrolled in another experimental (interventional) protocol within the past 30 days;pregnancy confirmed by urine or serum test; weight is > 200% of ideal body weight; immunosuppression including HIV+ status;severe chronic liver disease (Child-Pugh Class C score > 10 points) |
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E.5 End points |
E.5.1 | Primary end point(s) |
All-cause 28 day mortality, defined as the proportion of patients alive in each group under study day 28 at midnight |
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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 | No |
E.6.4 | Safety | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |