Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients

June 23, 2008 updated by: Debiopharm International SA

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

The study is aimed to assess safety of Depelestat treatment, as well as efficacy on prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients suffering from persistent Acute Respiratory Distress Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomised, double-blind, parallel groups, placebo-controlled, 1 week treatment of Depelestat, in patients suffering from persistent ARDS.

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Alain Mercat
      • Bordeaux, France, 33076
        • Yves Castaing
      • Créteil Cedex, France, 94010
        • Laurent Brochard
      • Grenoble Cedex 09, France, 38043
        • Jean-François Timsit
      • Lyon, France, 69004
        • Claude Guerin
      • Montpellier Cedex 05, France, 34295
        • Samir Jaber
      • Paris, France, 75651
        • Jean-Jacques Rouby
      • Paris Cedex, France, 75679
        • Jean-Daniel Chiche
      • Paris Cedex 15, France, 75908
        • Jean-Yves Fagon
      • Rouen Cedex, France, 76031
        • Jean-Christophe Richard
      • Toulon, France, 83100
        • Jean-Michel Arnal
  • Italy
      • Roma, Italy, 00168
        • Massimo Antonelli
  • Spain
      • Barcelona, Spain, 08025
        • Jordi Mancebo D.
  • Tunisia
      • Monastir, Tunisia
        • Fekri Abroug

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from persistent ARDS as defined by the American and European Consensus Conference on ARDS, 1994

Exclusion Criteria:

  • ARDS secondary to traumatism
  • Pulmonary emphysema on pulmonary fibrosis
  • Lung pneumocystosis
  • Bronchopleural fistula
  • Systemic corticosteroid treatment for more than 2 weeks before inclusion
  • Severe organ disease excepted renal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Drug: Placebo
Placebo
ACTIVE_COMPARATOR: 1
Depelestat
Drug: EPI-hNE4
I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Static compliance relative change from pre-treatment to last on treatment

Secondary Outcome Measures

Outcome Measure
PCPIII and cytokines concentration, as well as neutrophil influx relative change in BAL fluid from pre-treatment to post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Debiopharm International SA

Investigators

  • Study Director: François Saudubray, MD, Debiopharm SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

March 14, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (ESTIMATE)

April 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2008

Last Update Submitted That Met QC Criteria

June 23, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEB-EPIV-201
  • 2006-000756-41 (EUDRACT NR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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