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

NCT ID: NCT00074906

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Venticute

Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia

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 Eligible Age

12 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger G. Spragg, MD

Role: PRINCIPAL_INVESTIGATOR

University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA

Werner Seeger, MD

Role: PRINCIPAL_INVESTIGATOR

Justus-Liebig-Universität, Gießen, Germany

Andreas Günther, MD

Role: PRINCIPAL_INVESTIGATOR

University of Giessen

Locations

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Altana Pharma/Nycomed

Adelaide SA, , Australia

Site Status

Altana Pharma/Nycomed

Bedford Park, Adelaide S, , Australia

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Altana Pharma/Nycomed

Clayton, VIC, , Australia

Site Status

Altana Pharma/Nycomed

Fremantle, WA, , Australia

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Altana Pharma/Nycomed

Heidelberg, Victoria, , Australia

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Altana Pharma/Nycomed

Kingswood, Sydney, NS, , Australia

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Altana Pharma/Nycomed

Melbourne VIC, , Australia

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Altana Pharma/Nycomed

Perth, Western Australi, , Australia

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Altana Pharma/Nycomed

Southport Gold Coast QL, , Australia

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Altana Pharma/Nycomed

Victoria, , Australia

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Altana Pharma/Nycomed

Victoria, , Australia

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Altana Pharma/Nycomed

Woolloongabba, Queens, , Australia

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Altana Pharma/Nycomed

Linz, , Austria

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Altana Pharma/Nycomed

Vienna, , Austria

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Edegern, , Belgium

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Altana Pharma/Nycomed

Ghent, , Belgium

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Altana Pharma/Nycomed

Copenhagen NV, , Denmark

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Altana Pharma/Nycomed

Hvidovre, , Denmark

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Altana Pharma/Nycomed

Kolding, , Denmark

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Altana Pharma/Nycomed

Tallinn, , Estonia

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Altana Pharma/Nycomed

Tartu, , Estonia

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Altana Pharma/Nycomed

Jyväskylä, , Finland

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Altana Pharma/Nycomed

Kuopio, , Finland

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Altana Pharma/Nycomed

Lappeenranta, , Finland

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Altana Pharma/Nycomed

Oulu, , Finland

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Altana Pharma/Nycomed

Tampere, , Finland

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Altana Pharma/Nycomed

Turku, , Finland

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Altana Pharma/Nycomed

Berlin, , Germany

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Altana Pharma/Nycomed

Bonn, , Germany

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Altana Pharma/Nycomed

Dresden, , Germany

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Altana Pharma/Nycomed

Giessen, , Germany

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Altana Pharma/Nycomed

Greifswald, , Germany

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Altana Pharma/Nycomed

Hanover, , Germany

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Altana Pharma/Nycomed

Hofheim, , Germany

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Altana Pharma/Nycomed

Konstanz, , Germany

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Altana Pharma/Nycomed

Lübeck, , Germany

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Altana Pharma/Nycomed

München, , Germany

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Altana Pharma/Nycomed

Regensburg, , Germany

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Altana Pharma/Nycomed

Tübingen, , Germany

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Altana Pharma/Nycomed

Athens, , Greece

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Altana Pharma/Nycomed

Dragana, Alexandroupoli, , Greece

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Altana Pharma/Nycomed

Thessaloniki, , Greece

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Altana Pharma/Nycomed

Voutes, Crete, , Greece

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Kistarcsa, , Hungary

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Altana Pharma/Nycomed

Szeged, , Hungary

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Altana Pharma/Nycomed

Székesfehérvár, , Hungary

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Altana Pharma/Nycomed

Vác, , Hungary

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Altana Pharma/Nycomed

Afula, , Israel

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Altana Pharma/Nycomed

Tel Litwinsky, , Israel

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Altana Pharma/Nycomed

Ẕerifin, , Israel

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Altana Pharma/Nycomed

Breda, , Netherlands

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Altana Pharma/Nycomed

Heerlen, , Netherlands

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Altana Pharma/Nycomed

Rotterdam, , Netherlands

Site Status

Altana Pharma/Nycomed

Tilburg, , Netherlands

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Altana Pharma/Nycomed

Christchurch, , New Zealand

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Altana Pharma/Nycomed

Hastings, , New Zealand

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Altana Pharma/Nycomed

Wellington, , New Zealand

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Johannesburg, , South Africa

Site Status

Altana Pharma/Nycomed

Queenswood, , South Africa

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Altana Pharma/Nycomed

Badajoz, , Spain

Site Status

Altana Pharma/Nycomed

Barcelona, , Spain

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Altana Pharma/Nycomed

Barcelona, , Spain

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Altana Pharma/Nycomed

Getafe (Madrid), , Spain

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Altana Pharma/Nycomed

Granada, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Palma de Mallorca, , Spain

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Altana Pharma/Nycomed

Seville, , Spain

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Altana Pharma/Nycomed

Seville, , Spain

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Altana Pharma/Nycomed

Bern, , Switzerland

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Altana Pharma/Nycomed

Lugano, , Switzerland

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Altana Pharma/Nycomed

Winterthur, , Switzerland

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Altana Pharma/Nycomed

Zurich, , Switzerland

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Altana Pharma/Nycomed

Budapest, , United Kingdom

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Altana Pharma/Nycomed

Cardiff, , United Kingdom

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Altana Pharma/Nycomed

Cottingham, , United Kingdom

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Altana Pharma/Nycomed

Kings Lynn, Norfolk, , United Kingdom

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Altana Pharma/Nycomed

Leeds, , United Kingdom

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Altana Pharma/Nycomed

Leeds, , United Kingdom

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Altana Pharma/Nycomed

Nottingham, , United Kingdom

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Altana Pharma/Nycomed

Reading, , United Kingdom

Site Status

Altana Pharma/Nycomed

West Lothian, , United Kingdom

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Countries

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

References

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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.

Reference Type DERIVED
PMID: 21148720 (View on PubMed)

Other Identifiers

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BY2001/M1-007

Identifier Type: -

Identifier Source: org_study_id

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