Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455767
Status:
COMPLETED
Last Update Posted:
2008-06-24
First Post:
2007-03-14
Brief Title:
Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome ARDS Patients
Sponsor:
Debiopharm International SA
Organization:
Debiopharm International SA
Study Overview
Official Title:
Phase IIA Multicenter 1 Week Treatment Randomised Double-Blind Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-000756-41 EUDRACT NR | None | None | None |