EUCTR2006-000756-41-BEActive, not recruitingNot Applicable
Phase IIa Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering from Acute Respiratory Distress Syndrome
Debiopharm SA0 sites80 target enrollmentStarted: March 10, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •A) Patients suffering from persistent ARDS defined as follows :
- •ARDS 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 less than or equal to 200 mm Hg
- •- no sign of left atrial hypertension (congestive heart failure)
- •Persistence defined by:
- •- Pa02/FI02 ratio of less than or equal to 200 mm Hg under invasive ventilation, with a PEEP level of higher than or equal to 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 less than or equal to 90 kg : predicted body weight of male patients is calculated as equal to 50 + 0.91 (cms of height – 152.4); that of female patients as equal to 45.5 + 0.91 (cms of height – 152.4)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- positive pregnancy test in woman of childbearing potential
- •- patients suffering from pulmonary emphysema before ARDS occurred, with a TLC value higher than 130 % predicted
- •- patients suffering from pulmonary fibrosis before ARDS occurred, with a TLC value less than or equal to 70 % predicted
- •- patients with ARDS secondary to traumatism
- •- patients suffering from ALI with a Pa02/FI02 ratio of less than or equal to 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 higher than or equal to 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 less than or equal to 80 mm Hg, whatever the level of PEEP, contraindicating the BAL
- •- patients with severe organ diseases :
- •(a) renal failure : specific renal SOFA score = 4 or under dialysis
- •(b) 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
- •(c) hepatic failure: specific hepatic SOFA score = 4 or Child-Pugh score class C
- •(d)neutropenia: blood neutrophil count < 1000/mm3, or neutropenia expected because of ongoing cytostatic treatment
- •(e) patients having received a bone marrow transplantation
- •- patients already included in another therapeutical trial
Investigators
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