Clinical trial NCT00074906: Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: Aspiration of gastric contents
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2003-12-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Survival on day 28
timeFrame: 28 days
Secondary outcomes:
measure: How long the lung and the patient (overall) are recovering
timeFrame: 28 days
Other outcomes:
Locations:
city: Adelaide SA
country: Australia
facility: Altana Pharma/Nycomed
city: Bedford Park, Adelaide S
country: Australia
facility: Altana Pharma/Nycomed
city: Clayton, VIC
country: Australia
facility: Altana Pharma/Nycomed
city: Fremantle, WA
country: Australia
facility: Altana Pharma/Nycomed
city: Heidelberg, Victoria
country: Australia
facility: Altana Pharma/Nycomed
city: Kingswood, Sydney, NS
country: Australia
facility: Altana Pharma/Nycomed
city: Melbourne VIC
country: Australia
facility: Altana Pharma/Nycomed
city: Perth, Western Australi
country: Australia
facility: Altana Pharma/Nycomed
city: Southport Gold Coast QL
country: Australia
facility: Altana Pharma/Nycomed
city: Victoria
country: Australia
facility: Altana Pharma/Nycomed
city: Victoria
country: Australia
facility: Altana Pharma/Nycomed
city: Woolloongabba, Queens
country: Australia
facility: Altana Pharma/Nycomed
city: Linz
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Brussels
country: Belgium
facility: Altana Pharma/Nycomed
city: Brussels
country: Belgium
facility: Altana Pharma/Nycomed
city: Edegern
country: Belgium
facility: Altana Pharma/Nycomed
city: Gent
country: Belgium
facility: Altana Pharma/Nycomed
city: Copenhagen NV
country: Denmark
facility: Altana Pharma/Nycomed
city: Hvidovre
country: Denmark
facility: Altana Pharma/Nycomed
city: Kolding
country: Denmark
facility: Altana Pharma/Nycomed
city: Tallinn
country: Estonia
facility: Altana Pharma/Nycomed
city: Tartu
country: Estonia
facility: Altana Pharma/Nycomed
city: Jyväskylä
country: Finland
facility: Altana Pharma/Nycomed
city: Kuopio
country: Finland
facility: Altana Pharma/Nycomed
city: Lappeenranta
country: Finland
facility: Altana Pharma/Nycomed
city: Oulu
country: Finland
facility: Altana Pharma/Nycomed
city: Tampere
country: Finland
facility: Altana Pharma/Nycomed
city: Turku
country: Finland
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Bonn
country: Germany
facility: Altana Pharma/Nycomed
city: Dresden
country: Germany
facility: Altana Pharma/Nycomed
city: Giessen
country: Germany
facility: Altana Pharma/Nycomed
city: Greifswald
country: Germany
facility: Altana Pharma/Nycomed
city: Hannover
country: Germany
facility: Altana Pharma/Nycomed
city: Hofheim
country: Germany
facility: Altana Pharma/Nycomed
city: Konstanz
country: Germany
facility: Altana Pharma/Nycomed
city: Lübeck
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: Regensburg
country: Germany
facility: Altana Pharma/Nycomed
city: Tübingen
country: Germany
facility: Altana Pharma/Nycomed
city: Athen
country: Greece
facility: Altana Pharma/Nycomed
city: Dragana, Alexandroupoli
country: Greece
facility: Altana Pharma/Nycomed
city: Thessaloniki
country: Greece
facility: Altana Pharma/Nycomed
city: Voutes, Crete
country: Greece
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Kistarcsa
country: Hungary
facility: Altana Pharma/Nycomed
city: Szeged
country: Hungary
facility: Altana Pharma/Nycomed
city: Székesfehérvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Vác
country: Hungary
facility: Altana Pharma/Nycomed
city: Afula
country: Israel
facility: Altana Pharma/Nycomed
city: Tel Hashomer
country: Israel
facility: Altana Pharma/Nycomed
city: Zerifin
country: Israel
facility: Altana Pharma/Nycomed
city: Breda
country: Netherlands
facility: Altana Pharma/Nycomed
city: Heerlen
country: Netherlands
facility: Altana Pharma/Nycomed
city: Rotterdam
country: Netherlands
facility: Altana Pharma/Nycomed
city: Tilburg
country: Netherlands
facility: Altana Pharma/Nycomed
city: Christchurch
country: New Zealand
facility: Altana Pharma/Nycomed
city: Hastings
country: New Zealand
facility: Altana Pharma/Nycomed
city: Wellington
country: New Zealand
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Johannesburg
country: South Africa
facility: Altana Pharma/Nycomed
city: Queenswood
country: South Africa
facility: Altana Pharma/Nycomed
city: Badajoz
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Getafe (Madrid)
country: Spain
facility: Altana Pharma/Nycomed
city: Granada
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Palma de Mallorca
country: Spain
facility: Altana Pharma/Nycomed
city: Sevilla
country: Spain
facility: Altana Pharma/Nycomed
city: Sevilla
country: Spain
facility: Altana Pharma/Nycomed
city: Bern
country: Switzerland
facility: Altana Pharma/Nycomed
city: Lugano
country: Switzerland
facility: Altana Pharma/Nycomed
city: Winterthur
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
city: Budapest
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Cardiff
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Cottingham
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Kings Lynn, Norfolk
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Leeds
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Leeds
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Nottingham
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Reading
country: United Kingdom
facility: Altana Pharma/Nycomed
city: West Lothian
country: United Kingdom
facility: Altana Pharma/Nycomed
Study officials:
affiliation: University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA
name: Roger G. Spragg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Justus-Liebig-Universität, Gießen, Germany
name: Werner Seeger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Giessen
name: Andreas Günther, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spragg RG, Taut FJ, Lewis JF, Schenk P, Ruppert C, Dean N, Krell K, Karabinis A, Gunther A. Recombinant surfactant protein C-based surfactant for patients with severe direct lung injury. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1055-61. doi: 10.1164/rccm.201009-1424OC. Epub 2010 Dec 10.