Status:
COMPLETED
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
Lead Sponsor:
Takeda
Conditions:
Pneumonia
Eligibility:
All Genders
12-85 years
Phase:
PHASE3
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 oxygenat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00074906
Start Date
November 1 2003
End Date
June 1 2008
Last Update
May 7 2012
Active Locations (92)
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1
Altana Pharma/Nycomed
Adelaide SA, Australia, 5000
2
Altana Pharma/Nycomed
Bedford Park, Adelaide S, Australia, 5042
3
Altana Pharma/Nycomed
Clayton, VIC, Australia, 3158
4
Altana Pharma/Nycomed
Fremantle, WA, Australia, 6959