Phase IIa Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering from Acute Respiratory Distress Syndrome

• Conditions: Acute Respiratory Distress Syndrome (ARDS)

• Registration Number: EUCTR2006-000756-41-BE
• Lead Sponsor: Debiopharm SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-10
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified