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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074906
• Other study ID #: BY2001/M1-007
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2003
• Last updated: May 4, 2012
• Start date: November 2003
• Est. completion date: June 2008

Study information

• Verified date: January 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Venticute
Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Denmark,  Estonia,  Finland,  Germany,  Greece,  Hungary,  Israel,  Netherlands,  New Zealand,  Russian Federation,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

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