A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.
Full description
Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflamed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing.
Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
- show evidence of acute lung injury
- be on mechanical ventilation
Exclusion Criteria
- have undergone certain organ transplants
- have severe underlying medical problems
- be unlikely to survive
- be pregnant or breast-feeding
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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