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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00074906
First received: December 23, 2003
Last updated: May 4, 2012
Last verified: January 2012
  Purpose

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
Pneumonia
Drug: Venticute
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

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
  Eligibility

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00074906

  Show 92 Study Locations
Sponsors and Collaborators
Takeda
Investigators
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

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00074906     History of Changes
Other Study ID Numbers: BY2001/M1-007
Study First Received: December 23, 2003
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Aspiration of gastric contents

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 01, 2014