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

Condition	Treatment or Intervention	Phase
Pneumonia	Drug: lusupultide	Phase III

Further Study Details: 

Expected Total Enrollment:  1200

Ages Eligible for Study:  12 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Patient has been intubated due to one of the following primary pulmonary insults: *aspiration of gastric contents *pneumonia

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

Bruce Wagman, MBA      1-484-679-2443    bruce.wagman@omnicarecr.com
Hank Fox      1-484-679-2571    Hank.Fox@omnicarecr.com

Pennsylvania
      Omnicare Clinical Research, King Of Prussia,  Pennsylvania,  19406,  United States; Recruiting

Study ID Numbers:  BY2001/M1-007
Record last reviewed:  January 2005
Last Updated:  January 31, 2005
Record first received:  December 23, 2003
ClinicalTrials.gov Identifier:  NCT00074906
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08