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Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
This study has been completed.
First Received: December 23, 2003   Last Updated: December 12, 2008   History of Changes
Sponsor: ALTANA Pharma
Information provided by: ALTANA Pharma
ClinicalTrials.gov Identifier: NCT00074906
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Pneumonia
Drug Information available for: Venticute
U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074906

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

Responsible Party: Nycomed ( Nycomed )
Study ID Numbers: BY2001/M1-007
Study First Received: December 23, 2003
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00074906     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:
Aspiration of gastric contents

Additional relevant MeSH terms:
Signs and Symptoms
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
 Signs and Symptoms, Respiratory
Respiratory Aspiration
Pneumonia, Aspiration
Pneumonia

ClinicalTrials.gov processed this record on November 30, 2009



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