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.

Official Title

Venticute in Patients With Pneumonia or Aspiration of Gastric Contents Leading to Intubation, Ventilation, and Severe Oxygenation Impairment: A Randomized, Multinational, Multicenter, Parallel Group, Double Blind, Control Group Study

Conditions

Pneumonia

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

  • Primary Outcome Measures: Survival on day 28
  • Secondary Outcome Measures: How quickly the lung and the patient overall are recovering.

Study Start

November 2003

Eligibility & Criteria

  • Ages Eligible for Study: 12 Years – 85 Years
  • Genders Eligible for Study: Both

Inclusion criteria:

  • Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or 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
  • Total Enrolment

    1200

    Contact Details

    • ALTANA Pharma, Cities in Australia, Australia; Recruiting
    • ALTANA Pharma Info: info.clintrials@altanapharma.com