E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute respiratory distress syndrome |
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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 | 10049874 |
E.1.2 | Term | Cardio-respiratory distress |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To assess the safety of Depelestat administered by IV route in critically ill patients suffering from persistent ARDS - To assess efficacy of Depelestat on prevention and treatment of alveolar inflammation by measuring relevant biological parameters in blood and BAL of ARDS patients - To assess efficacy of Depelestat on prevention of early pulmonary fibrosis in ARDS patients, by assaying biological markers of lung collagen turnover in BAL and by measuring static compliance of the respiratory system. |
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E.2.2 | Secondary objectives of the trial |
1-To assess the effect of Depelestat on the evolution of the clinical status of ARDS patients : - oxygenation by measuring Pa02/FI02 ratio; - multi-organ dysfunction; - ventilation-free days; - mortality; 2- To assess basic pharmacokinetics in ARDS patients. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a. Patients suffering from persistent ARDS defined as follows : ᄋARDS defined by: - acute respiratory failure on invasive or non invasive ventilation - bilateral pulmonary infiltrates on the chest X-ray, with a picture compatible with a pulmonary edema - Pa02/FI02 ratio of <= 200 mm Hg - no sign of left atrial hypertension (congestive heart failure) ᄋPersistence defined by: -Pa02/FI02 ratio of <= 200 mm Hg on invasive ventilation, with a PEEP level of >= 5 cm H2O, 12 to 24 hours after the ARDS criteria were met (under invasive mechanical ventilation), as defined by the French Conference Consensus b.Predicted body weight <= 90 kg. |
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E.4 | Principal exclusion criteria |
- positive pregnancy test in woman of childbearing potential; - patients suffering from pulmonary emphysema before ARDS occurred, with a TLC value > 130 % predicted; - patients suffering from pulmonary fibrosis before ARDS occurred, with a TLC value < 70 % predicted - patients with ARDS secondary to traumatism; - patients suffering from ALI with a Pa02/FI02 ratio of <= 300 mm Hg under non invasive or invasive ventilation, for more than 24 hours before ARDS criteria were met; - patients who are moribund and not expected to survive for more than 72 hours; - patients suffering from a lung pneumocystosis - patients with a bronchopleural fistula - patients having received a systemic corticosteroid treatment at a dose >= 0.5 mg/kg prednisolone for more than 2 weeks before inclusion; - patients whose family or physician are not committed to aggressive support for more than 72 hours - patients with Pa02/FI02 <= 80 mm Hg, whatever the level of PEEP, contraindicating the BAL; - patients with severe organ diseases : ᄃ renal failure : specific renal SOFA score = 4 or under dialysis; ᄃ cardiovascular failure : severe hemodynamic instability graded III by Jardin score, with persistent of metabolic acidosis, defined as a base deficit of > 5 mmol/L present for > 6 hours, despite administration of vasoactive drugs; ᄃ hepatic failure: specific hepatic SOFA score = 4 or Child-Pugh score class C; ᄃ neutropenia: blood neutrophil count < 1000/mm3, or neutropenia expected because of ongoing cytostatic treatment ᄃ patients having received a bone marrow transplantation - patients already included in another therapeutical trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
primary endpoint will be safety and efficacy on prevention and treatment of alveolar inflammation and early pulmonary fibrosis, according to the available pharmacologic data. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
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 | 10 |