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Clinical Trials/EUCTR2006-000756-41-BE
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

Sponsor
Debiopharm SA

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