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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00074906




Registration number
NCT00074906
Ethics application status
Date submitted
23/12/2003
Date registered
25/12/2003
Date last updated
7/05/2012

Titles & IDs
Public title
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
Scientific 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
Secondary ID [1] 0 0
BY2001/M1-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Venticute

Treatment: Drugs: Venticute
Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival on day 28
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
How long the lung and the patient (overall) are recovering
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion 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.
Minimum age
12 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Altana Pharma/Nycomed - Adelaide SA
Recruitment hospital [2] 0 0
Altana Pharma/Nycomed - Bedford Park, Adelaide S
Recruitment hospital [3] 0 0
Altana Pharma/Nycomed - Clayton, VIC
Recruitment hospital [4] 0 0
Altana Pharma/Nycomed - Fremantle, WA
Recruitment hospital [5] 0 0
Altana Pharma/Nycomed - Heidelberg, Victoria
Recruitment hospital [6] 0 0
Altana Pharma/Nycomed - Kingswood, Sydney, NS
Recruitment hospital [7] 0 0
Altana Pharma/Nycomed - Melbourne VIC
Recruitment hospital [8] 0 0
Altana Pharma/Nycomed - Perth, Western Australi
Recruitment hospital [9] 0 0
Altana Pharma/Nycomed - Southport Gold Coast QL
Recruitment hospital [10] 0 0
Altana Pharma/Nycomed - Victoria
Recruitment hospital [11] 0 0
Altana Pharma/Nycomed - Woolloongabba, Queens
Recruitment postcode(s) [1] 0 0
5000 - Adelaide SA
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park, Adelaide S
Recruitment postcode(s) [3] 0 0
3158 - Clayton, VIC
Recruitment postcode(s) [4] 0 0
6959 - Fremantle, WA
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg, Victoria
Recruitment postcode(s) [6] 0 0
2750 - Kingswood, Sydney, NS
Recruitment postcode(s) [7] 0 0
3004 - Melbourne VIC
Recruitment postcode(s) [8] 0 0
6000 - Perth, Western Australi
Recruitment postcode(s) [9] 0 0
4215 - Southport Gold Coast QL
Recruitment postcode(s) [10] 0 0
3050 - Victoria
Recruitment postcode(s) [11] 0 0
3128 - Victoria
Recruitment postcode(s) [12] 0 0
4102 - Woolloongabba, Queens
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegern
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen NV
Country [7] 0 0
Denmark
State/province [7] 0 0
Hvidovre
Country [8] 0 0
Denmark
State/province [8] 0 0
Kolding
Country [9] 0 0
Estonia
State/province [9] 0 0
Tallinn
Country [10] 0 0
Estonia
State/province [10] 0 0
Tartu
Country [11] 0 0
Finland
State/province [11] 0 0
Jyväskylä
Country [12] 0 0
Finland
State/province [12] 0 0
Kuopio
Country [13] 0 0
Finland
State/province [13] 0 0
Lappeenranta
Country [14] 0 0
Finland
State/province [14] 0 0
Oulu
Country [15] 0 0
Finland
State/province [15] 0 0
Tampere
Country [16] 0 0
Finland
State/province [16] 0 0
Turku
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Bonn
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Giessen
Country [21] 0 0
Germany
State/province [21] 0 0
Greifswald
Country [22] 0 0
Germany
State/province [22] 0 0
Hannover
Country [23] 0 0
Germany
State/province [23] 0 0
Hofheim
Country [24] 0 0
Germany
State/province [24] 0 0
Konstanz
Country [25] 0 0
Germany
State/province [25] 0 0
Lübeck
Country [26] 0 0
Germany
State/province [26] 0 0
München
Country [27] 0 0
Germany
State/province [27] 0 0
Regensburg
Country [28] 0 0
Germany
State/province [28] 0 0
Tübingen
Country [29] 0 0
Greece
State/province [29] 0 0
Athen
Country [30] 0 0
Greece
State/province [30] 0 0
Dragana, Alexandroupoli
Country [31] 0 0
Greece
State/province [31] 0 0
Thessaloniki
Country [32] 0 0
Greece
State/province [32] 0 0
Voutes, Crete
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Kistarcsa
Country [35] 0 0
Hungary
State/province [35] 0 0
Szeged
Country [36] 0 0
Hungary
State/province [36] 0 0
Székesfehérvár
Country [37] 0 0
Hungary
State/province [37] 0 0
Vác
Country [38] 0 0
Israel
State/province [38] 0 0
Afula
Country [39] 0 0
Israel
State/province [39] 0 0
Tel Hashomer
Country [40] 0 0
Israel
State/province [40] 0 0
Zerifin
Country [41] 0 0
Netherlands
State/province [41] 0 0
Breda
Country [42] 0 0
Netherlands
State/province [42] 0 0
Heerlen
Country [43] 0 0
Netherlands
State/province [43] 0 0
Rotterdam
Country [44] 0 0
Netherlands
State/province [44] 0 0
Tilburg
Country [45] 0 0
New Zealand
State/province [45] 0 0
Christchurch
Country [46] 0 0
New Zealand
State/province [46] 0 0
Hastings
Country [47] 0 0
New Zealand
State/province [47] 0 0
Wellington
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Moscow
Country [49] 0 0
South Africa
State/province [49] 0 0
Johannesburg
Country [50] 0 0
South Africa
State/province [50] 0 0
Queenswood
Country [51] 0 0
Spain
State/province [51] 0 0
Badajoz
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Getafe (Madrid)
Country [54] 0 0
Spain
State/province [54] 0 0
Granada
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Palma de Mallorca
Country [57] 0 0
Spain
State/province [57] 0 0
Sevilla
Country [58] 0 0
Switzerland
State/province [58] 0 0
Bern
Country [59] 0 0
Switzerland
State/province [59] 0 0
Lugano
Country [60] 0 0
Switzerland
State/province [60] 0 0
Winterthur
Country [61] 0 0
Switzerland
State/province [61] 0 0
Zürich
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Budapest
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Cardiff
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Cottingham
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Kings Lynn, Norfolk
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Leeds
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Nottingham
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Reading
Country [69] 0 0
United Kingdom
State/province [69] 0 0
West Lothian

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00074906
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Roger G. Spragg, MD
Address 0 0
University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00074906