Inflammation Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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