Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

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.