Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.

Official Title
-----------------
Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan

Conditions
-----------------
Acute Lung Injury, Systemic Inflammatory Response Syndrome

Intervention / Treatment
-----------------
* Drug: Sivelestat sodium hydrate
* Drug: Sivelestat sodium hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systemic inflammatory response syndrome (SIRS) Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference Within 72 hours of onset of lung injury Other inclusion criteria as specified in the protocol Exclusion Criteria: Already administrated Sivelestat before enrollment in the study Neuromuscular disease that impairs spontaneous ventilation Severe central nervous system disease Bone marrow transplant Lung transplant Severe chronic liver disease Neutropenia (neutrophil count: below 1000/mm3) Other exclusion criteria as specified in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E1<br>This arm is conducted as a separate study (12-601-0001) | Drug: Sivelestat sodium hydrate<br>* 0.2 mg/kg/hr continuous i.v. infusion - up to 14 days<br>|
| Experimental: E2<br>This arm is conducted as a separate study (12-603-0001). | Drug: Sivelestat sodium hydrate<br>* 0.2 mg/kg/hr continuous i.v. infusion - up to 14 days<br>|
| No Intervention: conventional therapy<br>This arm is conducted as a separate study (12-602-0001) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days (VFD) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elaspol, sivelestat sodium hydrate, acute lung injury, systemic inflammatory response syndrome, Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)