Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients
NCT ID: NCT00455767
Last Updated: 2008-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2006-07-31
2007-09-30
Brief Summary
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Detailed Description
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Patients admitted in the intensive care unit presenting ARDS criteria persistent for 12 hours to 24 hours, will be randomly assigned to the treatment by Depelestat or placebo, after a pre-treatment period as short as possible with a maximum of 48 hours since ARDS criteria are met. During the pre-treatment period, the informed consent will be obtained from the legally authorized relative of the patient, and pre-treatment biological and functional examinations will be performed, particularly blood samples and BAL for biological parameters measurement, and ventilatory mechanics, for assessment of static compliance of the respiratory system.
After the pre-treatment period, the patient will receive treatment by Depelestat or placebo during 7 days, or until extubation of the patient if this occurs before 7 days of treatment. During this treatment period, the patient will be submitted to a daily measurement of static compliance of the respiratory system, as long as the patient adaptation to 24 hours after mechanical ventilation allows the procedure, and at 96 initiation of treatment, to a blood sampling and a bronchoalveolar lavage for several biological parameters assessment.
On the first and last day of administration, blood will be also collected for pharmacokinetic evaluation.
During the post-treatment period, the patient will be submitted, at 48 h ± 24 h after the end of treatment, to a blood sampling and a BAL (this BAL is not performed when contraindication criteria are present, if the patient is already extubated, and in case of planed extubation during the subsequent 24 hours) for several biological parameters assessment, and a daily measurement of static compliance as long as the patient adaptation to mechanical ventilation allows the procedure. Patients already extubated will not be submitted to BAL nor to static compliance measurements.
After the end of the treatment, patients will be followed daily for 28 days after the diagnostic of ARDS, or until death whichever occurred first.
The duration of the study for each survivor patient will be 28 days. Survivors to day 28 will be contacted monthly to assess survival and fill in a QOL questionnaire on days 60 and 90.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Depelestat
EPI-hNE4
I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days
2
Placebo
Placebo
Placebo
Interventions
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EPI-hNE4
I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pulmonary emphysema on pulmonary fibrosis
* Lung pneumocystosis
* Bronchopleural fistula
* Systemic corticosteroid treatment for more than 2 weeks before inclusion
* Severe organ disease excepted renal
18 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Debiopharm S.A.
Principal Investigators
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François Saudubray, MD
Role: STUDY_DIRECTOR
Debiopharm SA
Locations
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Alain Mercat
Angers, , France
Yves Castaing
Bordeaux, , France
Laurent Brochard
Créteil, , France
Jean-François Timsit
Grenoble, , France
Claude Guerin
Lyon, , France
Samir Jaber
Montpellier, , France
Jean-Jacques Rouby
Paris, , France
Jean-Daniel Chiche
Paris, , France
Jean-Yves Fagon
Paris, , France
Jean-Christophe Richard
Rouen, , France
Jean-Michel Arnal
Toulon, , France
Massimo Antonelli
Roma, , Italy
Jordi Mancebo D.
Barcelona, , Spain
Fekri Abroug
Monastir, , Tunisia
Countries
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References
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Honore S, Attalah HL, Azoulay E, Soussy CJ, Saudubray F, Harf A, Brochard L, Delclaux C. Beneficial effect of an inhibitor of leukocyte elastase (EPI-hNE-4) in presence of repeated lung injuries. Shock. 2004 Aug;22(2):131-6. doi: 10.1097/01.shk.0000126861.77543.d0.
Related Links
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Related Info
Other Identifiers
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2006-000756-41 (EUDRACT NR)
Identifier Type: -
Identifier Source: secondary_id
DEB-EPIV-201
Identifier Type: -
Identifier Source: org_study_id