Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT00074906
Collaborator
(none)
1,200
92
55
13
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date
:
Nov 1, 2003
Actual Primary Completion Date
:
Mar 1, 2008
Actual Study Completion Date
:
Jun 1, 2008
Outcome Measures
Primary Outcome Measures
- Survival on day 28 [28 days]
Secondary Outcome Measures
- How long the lung and the patient (overall) are recovering [28 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Altana Pharma/Nycomed | Adelaide SA | Australia | 5000 | |
| 2 | Altana Pharma/Nycomed | Bedford Park, Adelaide S | Australia | 5042 | |
| 3 | Altana Pharma/Nycomed | Clayton, VIC | Australia | 3158 | |
| 4 | Altana Pharma/Nycomed | Fremantle, WA | Australia | 6959 | |
| 5 | Altana Pharma/Nycomed | Heidelberg, Victoria | Australia | 3084 | |
| 6 | Altana Pharma/Nycomed | Kingswood, Sydney, NS | Australia | 2750 | |
| 7 | Altana Pharma/Nycomed | Melbourne VIC | Australia | 3004 | |
| 8 | Altana Pharma/Nycomed | Perth, Western Australi | Australia | 6000 | |
| 9 | Altana Pharma/Nycomed | Southport Gold Coast QL | Australia | 4215 | |
| 10 | Altana Pharma/Nycomed | Victoria | Australia | 3050 | |
| 11 | Altana Pharma/Nycomed | Victoria | Australia | 3128 | |
| 12 | Altana Pharma/Nycomed | Woolloongabba, Queens | Australia | 4102 | |
| 13 | Altana Pharma/Nycomed | Linz | Austria | 4021 | |
| 14 | Altana Pharma/Nycomed | Wien | Austria | 1090 | |
| 15 | Altana Pharma/Nycomed | Brussels | Belgium | 1090 | |
| 16 | Altana Pharma/Nycomed | Brussels | Belgium | 1200 | |
| 17 | Altana Pharma/Nycomed | Edegern | Belgium | 2650 | |
| 18 | Altana Pharma/Nycomed | Gent | Belgium | 9000 | |
| 19 | Altana Pharma/Nycomed | Copenhagen NV | Denmark | 2400 | |
| 20 | Altana Pharma/Nycomed | Hvidovre | Denmark | 2650 | |
| 21 | Altana Pharma/Nycomed | Kolding | Denmark | 6000 | |
| 22 | Altana Pharma/Nycomed | Tallinn | Estonia | 13419 | |
| 23 | Altana Pharma/Nycomed | Tartu | Estonia | 51014 | |
| 24 | Altana Pharma/Nycomed | Jyväskylä | Finland | 40620 | |
| 25 | Altana Pharma/Nycomed | Kuopio | Finland | 70210 | |
| 26 | Altana Pharma/Nycomed | Lappeenranta | Finland | 53130 | |
| 27 | Altana Pharma/Nycomed | Oulu | Finland | 90220 | |
| 28 | Altana Pharma/Nycomed | Tampere | Finland | 33521 | |
| 29 | Altana Pharma/Nycomed | Turku | Finland | 20520 | |
| 30 | Altana Pharma/Nycomed | Berlin | Germany | 10117 | |
| 31 | Altana Pharma/Nycomed | Bonn | Germany | 53105 | |
| 32 | Altana Pharma/Nycomed | Dresden | Germany | 1307 | |
| 33 | Altana Pharma/Nycomed | Giessen | Germany | 35392 | |
| 34 | Altana Pharma/Nycomed | Greifswald | Germany | 17489 | |
| 35 | Altana Pharma/Nycomed | Hannover | Germany | 30625 | |
| 36 | Altana Pharma/Nycomed | Hofheim | Germany | 65702 | |
| 37 | Altana Pharma/Nycomed | Konstanz | Germany | 78464 | |
| 38 | Altana Pharma/Nycomed | Lübeck | Germany | 23538 | |
| 39 | Altana Pharma/Nycomed | München | Germany | 81377 | |
| 40 | Altana Pharma/Nycomed | Regensburg | Germany | 93042 | |
| 41 | Altana Pharma/Nycomed | Tübingen | Germany | 72076 | |
| 42 | Altana Pharma/Nycomed | Athen | Greece | 11527 | |
| 43 | Altana Pharma/Nycomed | Dragana, Alexandroupoli | Greece | 68100 | |
| 44 | Altana Pharma/Nycomed | Thessaloniki | Greece | 54636 | |
| 45 | Altana Pharma/Nycomed | Voutes, Crete | Greece | 71110 | |
| 46 | Altana Pharma/Nycomed | Budapest | Hungary | 1034 | |
| 47 | Altana Pharma/Nycomed | Budapest | Hungary | 1085 | |
| 48 | Altana Pharma/Nycomed | Budapest | Hungary | 1106 | |
| 49 | Altana Pharma/Nycomed | Budapest | Hungary | 1125 | |
| 50 | Altana Pharma/Nycomed | Kistarcsa | Hungary | 2143 | |
| 51 | Altana Pharma/Nycomed | Szeged | Hungary | 6720 | |
| 52 | Altana Pharma/Nycomed | Székesfehérvár | Hungary | 8000 | |
| 53 | Altana Pharma/Nycomed | Vác | Hungary | 2600 | |
| 54 | Altana Pharma/Nycomed | Afula | Israel | 18101 | |
| 55 | Altana Pharma/Nycomed | Tel Hashomer | Israel | 52621 | |
| 56 | Altana Pharma/Nycomed | Zerifin | Israel | 70300 | |
| 57 | Altana Pharma/Nycomed | Breda | Netherlands | 4818 CK | |
| 58 | Altana Pharma/Nycomed | Heerlen | Netherlands | 6401 CX | |
| 59 | Altana Pharma/Nycomed | Rotterdam | Netherlands | 3000 CA | |
| 60 | Altana Pharma/Nycomed | Tilburg | Netherlands | 5022 GC | |
| 61 | Altana Pharma/Nycomed | Christchurch | New Zealand | 8001 | |
| 62 | Altana Pharma/Nycomed | Hastings | New Zealand | 4201 | |
| 63 | Altana Pharma/Nycomed | Wellington | New Zealand | 6002 | |
| 64 | Altana Pharma/Nycomed | Moscow | Russian Federation | 105203 | |
| 65 | Altana Pharma/Nycomed | Moscow | Russian Federation | 111539 | |
| 66 | Altana Pharma/Nycomed | Moscow | Russian Federation | 115093 | |
| 67 | Altana Pharma/Nycomed | Moscow | Russian Federation | 115446 | |
| 68 | Altana Pharma/Nycomed | Moscow | Russian Federation | 123448 | |
| 69 | Altana Pharma/Nycomed | Johannesburg | South Africa | 2006 | |
| 70 | Altana Pharma/Nycomed | Queenswood | South Africa | 121 | |
| 71 | Altana Pharma/Nycomed | Badajoz | Spain | 6080 | |
| 72 | Altana Pharma/Nycomed | Barcelona | Spain | 6080 | |
| 73 | Altana Pharma/Nycomed | Barcelona | Spain | 8035 | |
| 74 | Altana Pharma/Nycomed | Getafe (Madrid) | Spain | 28905 | |
| 75 | Altana Pharma/Nycomed | Granada | Spain | 18013 | |
| 76 | Altana Pharma/Nycomed | Madrid | Spain | 28046 | |
| 77 | Altana Pharma/Nycomed | Palma de Mallorca | Spain | 7012 | |
| 78 | Altana Pharma/Nycomed | Sevilla | Spain | 41013 | |
| 79 | Altana Pharma/Nycomed | Sevilla | Spain | 41014 | |
| 80 | Altana Pharma/Nycomed | Bern | Switzerland | 3010 | |
| 81 | Altana Pharma/Nycomed | Lugano | Switzerland | 6900 | |
| 82 | Altana Pharma/Nycomed | Winterthur | Switzerland | 8400 | |
| 83 | Altana Pharma/Nycomed | Zürich | Switzerland | 8091 | |
| 84 | Altana Pharma/Nycomed | Budapest | United Kingdom | 1204 | |
| 85 | Altana Pharma/Nycomed | Cardiff | United Kingdom | CF14 4XW | |
| 86 | Altana Pharma/Nycomed | Cottingham | United Kingdom | HU16 5JQ | |
| 87 | Altana Pharma/Nycomed | Kings Lynn, Norfolk | United Kingdom | PE30 4ET | |
| 88 | Altana Pharma/Nycomed | Leeds | United Kingdom | LS1 3EX | |
| 89 | Altana Pharma/Nycomed | Leeds | United Kingdom | LS9 7JT | |
| 90 | Altana Pharma/Nycomed | Nottingham | United Kingdom | NG7 2UH | |
| 91 | Altana Pharma/Nycomed | Reading | United Kingdom | RG1 5AN | |
| 92 | Altana Pharma/Nycomed | West Lothian | United Kingdom | EHS4 6PP |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT00074906
Other Study ID Numbers:
- BY2001/M1-007
First Posted:
Dec 25, 2003
Last Update Posted:
May 7, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Takeda
Additional relevant MeSH terms: