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Completed

NCT Number: NCT00074906

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

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

12 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Adelaide SA, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venticute

Drug

Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment

Primary outcomes

  1. Survival on day 28

    Time frame: 28 days

Secondary outcomes

  1. How long the lung and the patient (overall) are recovering

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Dec 25, 2003
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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