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

May 4, 2012 updated by: Takeda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide SA, Australia, 5000
        • Altana Pharma/Nycomed
      • Bedford Park, Adelaide S, Australia, 5042
        • Altana Pharma/Nycomed
      • Clayton, VIC, Australia, 3158
        • Altana Pharma/Nycomed
      • Fremantle, WA, Australia, 6959
        • Altana Pharma/Nycomed
      • Heidelberg, Victoria, Australia, 3084
        • Altana Pharma/Nycomed
      • Kingswood, Sydney, NS, Australia, 2750
        • Altana Pharma/Nycomed
      • Melbourne VIC, Australia, 3004
        • Altana Pharma/Nycomed
      • Perth, Western Australi, Australia, 6000
        • Altana Pharma/Nycomed
      • Southport Gold Coast QL, Australia, 4215
        • Altana Pharma/Nycomed
      • Victoria, Australia, 3050
        • Altana Pharma/Nycomed
      • Victoria, Australia, 3128
        • Altana Pharma/Nycomed
      • Woolloongabba, Queens, Australia, 4102
        • Altana Pharma/Nycomed
  • Austria
      • Linz, Austria, 4021
        • Altana Pharma/Nycomed
      • Wien, Austria, 1090
        • Altana Pharma/Nycomed
  • Belgium
      • Brussels, Belgium, 1090
        • Altana Pharma/Nycomed
      • Brussels, Belgium, 1200
        • Altana Pharma/Nycomed
      • Edegern, Belgium, 2650
        • Altana Pharma/Nycomed
      • Gent, Belgium, 9000
        • Altana Pharma/Nycomed
  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Altana Pharma/Nycomed
      • Hvidovre, Denmark, 2650
        • Altana Pharma/Nycomed
      • Kolding, Denmark, 6000
        • Altana Pharma/Nycomed
  • Estonia
      • Tallinn, Estonia, 13419
        • Altana Pharma/Nycomed
      • Tartu, Estonia, 51014
        • Altana Pharma/Nycomed
  • Finland
      • Jyväskylä, Finland, 40620
        • Altana Pharma/Nycomed
      • Kuopio, Finland, 70210
        • Altana Pharma/Nycomed
      • Lappeenranta, Finland, 53130
        • Altana Pharma/Nycomed
      • Oulu, Finland, 90220
        • Altana Pharma/Nycomed
      • Tampere, Finland, 33521
        • Altana Pharma/Nycomed
      • Turku, Finland, 20520
        • Altana Pharma/Nycomed
  • Germany
      • Berlin, Germany, 10117
        • Altana Pharma/Nycomed
      • Bonn, Germany, 53105
        • Altana Pharma/Nycomed
      • Dresden, Germany, 1307
        • Altana Pharma/Nycomed
      • Giessen, Germany, 35392
        • Altana Pharma/Nycomed
      • Greifswald, Germany, 17489
        • Altana Pharma/Nycomed
      • Hannover, Germany, 30625
        • Altana Pharma/Nycomed
      • Hofheim, Germany, 65702
        • Altana Pharma/Nycomed
      • Konstanz, Germany, 78464
        • Altana Pharma/Nycomed
      • Lübeck, Germany, 23538
        • Altana Pharma/Nycomed
      • München, Germany, 81377
        • Altana Pharma/Nycomed
      • Regensburg, Germany, 93042
        • Altana Pharma/Nycomed
      • Tübingen, Germany, 72076
        • Altana Pharma/Nycomed
  • Greece
      • Athen, Greece, 11527
        • Altana Pharma/Nycomed
      • Dragana, Alexandroupoli, Greece, 68100
        • Altana Pharma/Nycomed
      • Thessaloniki, Greece, 54636
        • Altana Pharma/Nycomed
      • Voutes, Crete, Greece, 71110
        • Altana Pharma/Nycomed
  • Hungary
      • Budapest, Hungary, 1125
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1034
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1085
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1106
        • Altana Pharma/Nycomed
      • Kistarcsa, Hungary, 2143
        • Altana Pharma/Nycomed
      • Szeged, Hungary, 6720
        • Altana Pharma/Nycomed
      • Székesfehérvár, Hungary, 8000
        • Altana Pharma/Nycomed
      • Vác, Hungary, 2600
        • Altana Pharma/Nycomed
  • Israel
      • Afula, Israel, 18101
        • Altana Pharma/Nycomed
      • Tel Hashomer, Israel, 52621
        • Altana Pharma/Nycomed
      • Zerifin, Israel, 70300
        • Altana Pharma/Nycomed
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Altana Pharma/Nycomed
      • Heerlen, Netherlands, 6401 CX
        • Altana Pharma/Nycomed
      • Rotterdam, Netherlands, 3000 CA
        • Altana Pharma/Nycomed
      • Tilburg, Netherlands, 5022 GC
        • Altana Pharma/Nycomed
  • New Zealand
      • Christchurch, New Zealand, 8001
        • Altana Pharma/Nycomed
      • Hastings, New Zealand, 4201
        • Altana Pharma/Nycomed
      • Wellington, New Zealand, 6002
        • Altana Pharma/Nycomed
  • Russian Federation
      • Moscow, Russian Federation, 105203
        • Altana Pharma/Nycomed
      • Moscow, Russian Federation, 111539
        • Altana Pharma/Nycomed
      • Moscow, Russian Federation, 115093
        • Altana Pharma/Nycomed
      • Moscow, Russian Federation, 115446
        • Altana Pharma/Nycomed
      • Moscow, Russian Federation, 123448
        • Altana Pharma/Nycomed
  • South Africa
      • Johannesburg, South Africa, 2006
        • Altana Pharma/Nycomed
      • Queenswood, South Africa, 121
        • Altana Pharma/Nycomed
  • Spain
      • Badajoz, Spain, 6080
        • Altana Pharma/Nycomed
      • Barcelona, Spain, 6080
        • Altana Pharma/Nycomed
      • Barcelona, Spain, 8035
        • Altana Pharma/Nycomed
      • Getafe (Madrid), Spain, 28905
        • Altana Pharma/Nycomed
      • Granada, Spain, 18013
        • Altana Pharma/Nycomed
      • Madrid, Spain, 28046
        • Altana Pharma/Nycomed
      • Palma de Mallorca, Spain, 7012
        • Altana Pharma/Nycomed
      • Sevilla, Spain, 41013
        • Altana Pharma/Nycomed
      • Sevilla, Spain, 41014
        • Altana Pharma/Nycomed
  • Switzerland
      • Bern, Switzerland, 3010
        • Altana Pharma/Nycomed
      • Lugano, Switzerland, 6900
        • Altana Pharma/Nycomed
      • Winterthur, Switzerland, 8400
        • Altana Pharma/Nycomed
      • Zürich, Switzerland, 8091
        • Altana Pharma/Nycomed
  • United Kingdom
      • Budapest, United Kingdom, 1204
        • Altana Pharma/Nycomed
      • Cardiff, United Kingdom, CF14 4XW
        • Altana Pharma/Nycomed
      • Cottingham, United Kingdom, HU16 5JQ
        • Altana Pharma/Nycomed
      • Kings Lynn, Norfolk, United Kingdom, PE30 4ET
        • Altana Pharma/Nycomed
      • Leeds, United Kingdom, LS1 3EX
        • Altana Pharma/Nycomed
      • Leeds, United Kingdom, LS9 7JT
        • Altana Pharma/Nycomed
      • Nottingham, United Kingdom, NG7 2UH
        • Altana Pharma/Nycomed
      • Reading, United Kingdom, RG1 5AN
        • Altana Pharma/Nycomed
      • West Lothian, United Kingdom, EHS4 6PP
        • Altana Pharma/Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival on day 28
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
How long the lung and the patient (overall) are recovering
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 23, 2003

First Submitted That Met QC Criteria

December 24, 2003

First Posted (Estimate)

December 25, 2003

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY2001/M1-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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