Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Takeda Identifier:
First received: December 23, 2003
Last updated: May 4, 2012
Last verified: January 2012
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 Intervention Phase
Drug: Venticute
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Survival on day 28 [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • How long the lung and the patient (overall) are recovering [ Time Frame: 28 days ]

Estimated Enrollment: 1200
Study Start Date: November 2003
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Venticute
    Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment

Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00074906

  Show 92 Study Locations
Sponsors and Collaborators
Principal Investigator: Roger G. Spragg, MD University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA
Principal Investigator: Werner Seeger, MD Justus-Liebig-Universität, Gießen, Germany
Principal Investigator: Andreas Günther, MD University of Giessen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Takeda Identifier: NCT00074906     History of Changes
Other Study ID Numbers: BY2001/M1-007
Study First Received: December 23, 2003
Last Updated: May 4, 2012

Keywords provided by Takeda:
Aspiration of gastric contents

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on April 26, 2017