Pneumonia
Conditions
Keywords
Aspiration of gastric contents
Brief summary
Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment.
Interventions
DRUGVenticute
Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria: * Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia Main
Exclusion criteria
* Principal source of infection or sepsis is outside the lung * Severe pre-existing lung disease * Cancer metastatic to the lung or any end stage malignancy * History of lung, liver, pancreas, small bowel, or bone marrow/stem cell transplantation * Patient is morbidly obese * Patient has a diagnosis of acute necrotizing pancreatitis Additional criteria may apply and examination by an investigator is required to determine eligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival on day 28 | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| How long the lung and the patient (overall) are recovering | 28 days |
Countries
Australia, Austria, Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Israel, Netherlands, New Zealand, Russia, South Africa, Spain, Switzerland, United Kingdom
Outcome results
None listed