Pneumonia Clinical Trial
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
Verified date | January 2012 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1200 |
Est. completion date | June 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Altana Pharma/Nycomed | Adelaide SA | |
Australia | Altana Pharma/Nycomed | Bedford Park, Adelaide S | |
Australia | Altana Pharma/Nycomed | Clayton, VIC | |
Australia | Altana Pharma/Nycomed | Fremantle, WA | |
Australia | Altana Pharma/Nycomed | Heidelberg, Victoria | |
Australia | Altana Pharma/Nycomed | Kingswood, Sydney, NS | |
Australia | Altana Pharma/Nycomed | Melbourne VIC | |
Australia | Altana Pharma/Nycomed | Perth, Western Australi | |
Australia | Altana Pharma/Nycomed | Southport Gold Coast QL | |
Australia | Altana Pharma/Nycomed | Victoria | |
Australia | Altana Pharma/Nycomed | Victoria | |
Australia | Altana Pharma/Nycomed | Woolloongabba, Queens | |
Austria | Altana Pharma/Nycomed | Linz | |
Austria | Altana Pharma/Nycomed | Wien | |
Belgium | Altana Pharma/Nycomed | Brussels | |
Belgium | Altana Pharma/Nycomed | Brussels | |
Belgium | Altana Pharma/Nycomed | Edegern | |
Belgium | Altana Pharma/Nycomed | Gent | |
Denmark | Altana Pharma/Nycomed | Copenhagen NV | |
Denmark | Altana Pharma/Nycomed | Hvidovre | |
Denmark | Altana Pharma/Nycomed | Kolding | |
Estonia | Altana Pharma/Nycomed | Tallinn | |
Estonia | Altana Pharma/Nycomed | Tartu | |
Finland | Altana Pharma/Nycomed | Jyväskylä | |
Finland | Altana Pharma/Nycomed | Kuopio | |
Finland | Altana Pharma/Nycomed | Lappeenranta | |
Finland | Altana Pharma/Nycomed | Oulu | |
Finland | Altana Pharma/Nycomed | Tampere | |
Finland | Altana Pharma/Nycomed | Turku | |
Germany | Altana Pharma/Nycomed | Berlin | |
Germany | Altana Pharma/Nycomed | Bonn | |
Germany | Altana Pharma/Nycomed | Dresden | |
Germany | Altana Pharma/Nycomed | Giessen | |
Germany | Altana Pharma/Nycomed | Greifswald | |
Germany | Altana Pharma/Nycomed | Hannover | |
Germany | Altana Pharma/Nycomed | Hofheim | |
Germany | Altana Pharma/Nycomed | Konstanz | |
Germany | Altana Pharma/Nycomed | Lübeck | |
Germany | Altana Pharma/Nycomed | München | |
Germany | Altana Pharma/Nycomed | Regensburg | |
Germany | Altana Pharma/Nycomed | Tübingen | |
Greece | Altana Pharma/Nycomed | Athen | |
Greece | Altana Pharma/Nycomed | Dragana, Alexandroupoli | |
Greece | Altana Pharma/Nycomed | Thessaloniki | |
Greece | Altana Pharma/Nycomed | Voutes, Crete | |
Hungary | Altana Pharma/Nycomed | Budapest | |
Hungary | Altana Pharma/Nycomed | Budapest | |
Hungary | Altana Pharma/Nycomed | Budapest | |
Hungary | Altana Pharma/Nycomed | Budapest | |
Hungary | Altana Pharma/Nycomed | Kistarcsa | |
Hungary | Altana Pharma/Nycomed | Szeged | |
Hungary | Altana Pharma/Nycomed | Székesfehérvár | |
Hungary | Altana Pharma/Nycomed | Vác | |
Israel | Altana Pharma/Nycomed | Afula | |
Israel | Altana Pharma/Nycomed | Tel Hashomer | |
Israel | Altana Pharma/Nycomed | Zerifin | |
Netherlands | Altana Pharma/Nycomed | Breda | |
Netherlands | Altana Pharma/Nycomed | Heerlen | |
Netherlands | Altana Pharma/Nycomed | Rotterdam | |
Netherlands | Altana Pharma/Nycomed | Tilburg | |
New Zealand | Altana Pharma/Nycomed | Christchurch | |
New Zealand | Altana Pharma/Nycomed | Hastings | |
New Zealand | Altana Pharma/Nycomed | Wellington | |
Russian Federation | Altana Pharma/Nycomed | Moscow | |
Russian Federation | Altana Pharma/Nycomed | Moscow | |
Russian Federation | Altana Pharma/Nycomed | Moscow | |
Russian Federation | Altana Pharma/Nycomed | Moscow | |
Russian Federation | Altana Pharma/Nycomed | Moscow | |
South Africa | Altana Pharma/Nycomed | Johannesburg | |
South Africa | Altana Pharma/Nycomed | Queenswood | |
Spain | Altana Pharma/Nycomed | Badajoz | |
Spain | Altana Pharma/Nycomed | Barcelona | |
Spain | Altana Pharma/Nycomed | Barcelona | |
Spain | Altana Pharma/Nycomed | Getafe (Madrid) | |
Spain | Altana Pharma/Nycomed | Granada | |
Spain | Altana Pharma/Nycomed | Madrid | |
Spain | Altana Pharma/Nycomed | Palma de Mallorca | |
Spain | Altana Pharma/Nycomed | Sevilla | |
Spain | Altana Pharma/Nycomed | Sevilla | |
Switzerland | Altana Pharma/Nycomed | Bern | |
Switzerland | Altana Pharma/Nycomed | Lugano | |
Switzerland | Altana Pharma/Nycomed | Winterthur | |
Switzerland | Altana Pharma/Nycomed | Zürich | |
United Kingdom | Altana Pharma/Nycomed | Budapest | |
United Kingdom | Altana Pharma/Nycomed | Cardiff | |
United Kingdom | Altana Pharma/Nycomed | Cottingham | |
United Kingdom | Altana Pharma/Nycomed | Kings Lynn, Norfolk | |
United Kingdom | Altana Pharma/Nycomed | Leeds | |
United Kingdom | Altana Pharma/Nycomed | Leeds | |
United Kingdom | Altana Pharma/Nycomed | Nottingham | |
United Kingdom | Altana Pharma/Nycomed | Reading | |
United Kingdom | Altana Pharma/Nycomed | West Lothian |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Australia, Austria, Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Israel, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival on day 28 | 28 days | Yes | |
Secondary | How long the lung and the patient (overall) are recovering | 28 days | Yes |
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