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

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Venticute
Sponsored by
Takeda
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Aspiration of gastric contents

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Altana Pharma/Nycomed
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Outcomes

Primary Outcome Measures

Survival on day 28

Secondary Outcome Measures

How long the lung and the patient (overall) are recovering

Full Information

First Posted
December 23, 2003
Last Updated
May 4, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00074906
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Aspiration of gastric contents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Venticute
Intervention Description
Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
Primary Outcome Measure Information:
Title
Survival on day 28
Time Frame
28 days
Secondary Outcome Measure Information:
Title
How long the lung and the patient (overall) are recovering
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger G. Spragg, MD
Organizational Affiliation
University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Werner Seeger, MD
Organizational Affiliation
Justus-Liebig-Universität, Gießen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Günther, MD
Organizational Affiliation
University of Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Adelaide SA
ZIP/Postal Code
5000
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Bedford Park, Adelaide S
ZIP/Postal Code
5042
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Clayton, VIC
ZIP/Postal Code
3158
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Fremantle, WA
ZIP/Postal Code
6959
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Heidelberg, Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Kingswood, Sydney, NS
ZIP/Postal Code
2750
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Melbourne VIC
ZIP/Postal Code
3004
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Perth, Western Australi
ZIP/Postal Code
6000
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Southport Gold Coast QL
ZIP/Postal Code
4215
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Woolloongabba, Queens
ZIP/Postal Code
4102
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Edegern
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Altana Pharma/Nycomed
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Altana Pharma/Nycomed
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Altana Pharma/Nycomed
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Altana Pharma/Nycomed
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Altana Pharma/Nycomed
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Altana Pharma/Nycomed
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Altana Pharma/Nycomed
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Altana Pharma/Nycomed
City
Lappeenranta
ZIP/Postal Code
53130
Country
Finland
Facility Name
Altana Pharma/Nycomed
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Altana Pharma/Nycomed
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Altana Pharma/Nycomed
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Altana Pharma/Nycomed
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Hofheim
ZIP/Postal Code
65702
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Athen
ZIP/Postal Code
11527
Country
Greece
Facility Name
Altana Pharma/Nycomed
City
Dragana, Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
Altana Pharma/Nycomed
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Altana Pharma/Nycomed
City
Voutes, Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1034
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Vác
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Altana Pharma/Nycomed
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Altana Pharma/Nycomed
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Altana Pharma/Nycomed
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Heerlen
ZIP/Postal Code
6401 CX
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Altana Pharma/Nycomed
City
Christchurch
ZIP/Postal Code
8001
Country
New Zealand
Facility Name
Altana Pharma/Nycomed
City
Hastings
ZIP/Postal Code
4201
Country
New Zealand
Facility Name
Altana Pharma/Nycomed
City
Wellington
ZIP/Postal Code
6002
Country
New Zealand
Facility Name
Altana Pharma/Nycomed
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed
City
Moscow
ZIP/Postal Code
123448
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed
City
Johannesburg
ZIP/Postal Code
2006
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Queenswood
ZIP/Postal Code
121
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Badajoz
ZIP/Postal Code
6080
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Barcelona
ZIP/Postal Code
6080
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Getafe (Madrid)
ZIP/Postal Code
28905
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Granada
ZIP/Postal Code
18013
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Palma de Mallorca
ZIP/Postal Code
7012
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Altana Pharma/Nycomed
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1204
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Kings Lynn, Norfolk
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Leeds
ZIP/Postal Code
LS9 7JT
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
West Lothian
ZIP/Postal Code
EHS4 6PP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21148720
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.
Results Reference
derived

Learn more about this trial

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

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