PneumoniaPhase 3NCT00074906
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
A Phase 3 study testing Venticute in people with Pneumonia, run by Takeda at 92 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Venticute
- How many people
- 1,200 participants
- Where
- 92 sitesin 17 countries
- Study dates
- Nov 2003to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
92 sites in 17 countries.
92 sites in 17 countries
Australia12 sites
Altana Pharma/Nycomed
Adelaide SA, 5000
Altana Pharma/Nycomed
Bedford Park, Adelaide S, 5042
Altana Pharma/Nycomed
Clayton, VIC, 3158
Altana Pharma/Nycomed
Fremantle, WA, 6959
Altana Pharma/Nycomed
Heidelberg, Victoria, 3084
Altana Pharma/Nycomed
Kingswood, Sydney, NS, 2750
Altana Pharma/Nycomed
Melbourne VIC, 3004
Altana Pharma/Nycomed
Perth, Western Australi, 6000
Altana Pharma/Nycomed
Southport Gold Coast QL, 4215
Altana Pharma/Nycomed
Victoria, 3050
Altana Pharma/Nycomed
Victoria, 3128
Altana Pharma/Nycomed
Woolloongabba, Queens, 4102
Germany12 sites
Altana Pharma/Nycomed
Berlin, 10117
Altana Pharma/Nycomed
Bonn, 53105
Altana Pharma/Nycomed
Dresden, 1307
Altana Pharma/Nycomed
Giessen, 35392
Altana Pharma/Nycomed
Greifswald, 17489
Altana Pharma/Nycomed
Hanover, 30625
Altana Pharma/Nycomed
Hofheim, 65702
Altana Pharma/Nycomed
Konstanz, 78464
Altana Pharma/Nycomed
Lübeck, 23538
Altana Pharma/Nycomed
München, 81377
Altana Pharma/Nycomed
Regensburg, 93042
Altana Pharma/Nycomed
Tübingen, 72076
Spain9 sites
Altana Pharma/Nycomed
Badajoz, 6080
Altana Pharma/Nycomed
Barcelona, 6080
Altana Pharma/Nycomed
Barcelona, 8035
Altana Pharma/Nycomed
Getafe (Madrid), 28905
Altana Pharma/Nycomed
Granada, 18013
Altana Pharma/Nycomed
Madrid, 28046
Altana Pharma/Nycomed
Palma de Mallorca, 7012
Altana Pharma/Nycomed
Seville, 41013
Altana Pharma/Nycomed
Seville, 41014
United Kingdom9 sites
Altana Pharma/Nycomed
Budapest, 1204
Altana Pharma/Nycomed
Cardiff, CF14 4XW
Altana Pharma/Nycomed
Cottingham, HU16 5JQ
Altana Pharma/Nycomed
Kings Lynn, Norfolk, PE30 4ET
Altana Pharma/Nycomed
Leeds, LS1 3EX
Altana Pharma/Nycomed
Leeds, LS9 7JT
Altana Pharma/Nycomed
Nottingham, NG7 2UH
Altana Pharma/Nycomed
Reading, RG1 5AN
Altana Pharma/Nycomed
West Lothian, EHS4 6PP
Hungary8 sites
Altana Pharma/Nycomed
Budapest, 1034
Altana Pharma/Nycomed
Budapest, 1085
Altana Pharma/Nycomed
Budapest, 1106
Altana Pharma/Nycomed
Budapest, 1125
Altana Pharma/Nycomed
Kistarcsa, 2143
Altana Pharma/Nycomed
Szeged, 6720
Altana Pharma/Nycomed
Székesfehérvár, 8000
Altana Pharma/Nycomed
Vác, 2600
Finland6 sites
Altana Pharma/Nycomed
Jyväskylä, 40620
Altana Pharma/Nycomed
Kuopio, 70210
Altana Pharma/Nycomed
Lappeenranta, 53130
Altana Pharma/Nycomed
Oulu, 90220
Altana Pharma/Nycomed
Tampere, 33521
Altana Pharma/Nycomed
Turku, 20520
Russia5 sites
Altana Pharma/Nycomed
Moscow, 105203
Altana Pharma/Nycomed
Moscow, 111539
Altana Pharma/Nycomed
Moscow, 115093
Altana Pharma/Nycomed
Moscow, 115446
Altana Pharma/Nycomed
Moscow, 123448
Belgium4 sites
Altana Pharma/Nycomed
Brussels, 1090
Altana Pharma/Nycomed
Brussels, 1200
Altana Pharma/Nycomed
Edegern, 2650
Altana Pharma/Nycomed
Ghent, 9000
Greece4 sites
Altana Pharma/Nycomed
Athens, 11527
Altana Pharma/Nycomed
Dragana, Alexandroupoli, 68100
Altana Pharma/Nycomed
Thessaloniki, 54636
Altana Pharma/Nycomed
Voutes, Crete, 71110
Netherlands4 sites
Altana Pharma/Nycomed
Breda, 4818 CK
Altana Pharma/Nycomed
Heerlen, 6401 CX
Altana Pharma/Nycomed
Rotterdam, 3000 CA
Altana Pharma/Nycomed
Tilburg, 5022 GC
Switzerland4 sites
Altana Pharma/Nycomed
Bern, 3010
Altana Pharma/Nycomed
Lugano, 6900
Altana Pharma/Nycomed
Winterthur, 8400
Altana Pharma/Nycomed
Zurich, 8091
Denmark3 sites
Altana Pharma/Nycomed
Copenhagen NV, 2400
Altana Pharma/Nycomed
Hvidovre, 2650
Altana Pharma/Nycomed
Kolding, 6000
Israel3 sites
Altana Pharma/Nycomed
Afula, 18101
Altana Pharma/Nycomed
Tel HaShomer, 52621
Altana Pharma/Nycomed
Tsrifin, 70300
New Zealand3 sites
Altana Pharma/Nycomed
Christchurch, 8001
Altana Pharma/Nycomed
Hastings, 4201
Altana Pharma/Nycomed
Wellington, 6002
Austria2 sites
Altana Pharma/Nycomed
Linz, 4021
Altana Pharma/Nycomed
Vienna, 1090
Estonia2 sites
Altana Pharma/Nycomed
Tallinn, 13419
Altana Pharma/Nycomed
Tartu, 51014
South Africa2 sites
Altana Pharma/Nycomed
Johannesburg, 2006
Altana Pharma/Nycomed
Queenswood, 121
About this study
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 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.
- Conditions
- Pneumonia
- Being tested
- Venticute
- Keywords
- Aspiration of gastric contents
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenticuteDrug
Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival on day 28
Measured: 28 days
Secondary outcomes (1)
How long the lung and the patient (overall) are recovering
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2003 (estimated)
- Study startNov 2003
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger G. Spragg, MD, Principal investigator, University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USAWerner Seeger, MD, Principal investigator, Justus-Liebig-Universität, Gießen, GermanyAndreas Günther, MD, Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074906
- Sponsor's protocol ID
- BY2001/M1-007
- Status last verified
- Jan 2012
- First submitted
- 23 Dec 2003
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21148720
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00074906
- Acronym / sponsor ID
- BY2001/M1-007
- Conditions
- Pneumonia
- Keywords
- Aspiration of gastric contents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenticutePatients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment | Drug | – |
Primary outcome
Survival on day 28
Time frame: 28 days
1 secondary outcome
How long the lung and the patient (overall) are recovering
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
- Derived from this study: PubMed 21148720Spragg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger G. Spragg, MD principal investigator
University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA
Werner Seeger, MD principal investigator
Justus-Liebig-Universität, Gießen, Germany
Andreas Günther, MD principal investigator
University of Giessen
92 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Venticute in people with Pneumonia, run by Takeda at 92 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in Australia, Germany, Spain, United Kingdom, Hungary and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival on day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.