PneumoniaPhase 3NCT00084071
Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia
A Phase 3 study testing Tifacogin in people with Pneumonia, run by Novartis Pharmaceuticals at 150 sites in 18 countries.
Trial summary
The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia
- What is being tested?
- Tifacogin
- How many people
- 2,136 participants
- Where
- 150 sitesin 18 countries
- Study dates
- May 2004to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence
- Pneumonia of sufficient severity to require ICU admission and management
Who cannot join
- Pregnancy
- Weight over 150 kg
- Patients at increased risk of bleeding
- Treatment with drotrecogin alfa or anticipated need for drotrecogin alfa
- Treatment with heparin or anticipated need for heparin
Trial locations and contacts
150 sites in 18 countries.
150 sites in 18 countries
United States51 sites
Study site
Allentown, Pennsylvania
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Bay Pines, Florida, 33744
Study site
Buffalo, New York
Study site
Butte, Montana
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Columbus, Ohio
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Conyers, Georgia
Study site
Cumberland, Maryland
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Dallas, Texas
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Decatur, Georgia
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Denver, Colorado
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Detroit, Michigan
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Farmington, Connecticut
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Fort Lauderdale, Florida
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Greensboro, North Carolina
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Jacksonville, Florida
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Johnson City, New York
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Knoxville, Tennessee
Study site
Loma Linda, California
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Los Angeles, California
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Mobile, Alabama
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Muncie, Indiana
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New Albany, Indiana
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New Haven, Connecticut
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Newark, Delaware
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Norfolk, Virginia
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Oak Park, Illinois
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Oklahoma City, Oklahoma
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Orange, California
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Pawtucket, Rhode Island
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Providence, Rhode Island
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Reno, Nevada
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Sacramento, California
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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San Jose, California
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Seattle, Washington
Study site
Shreveport, Louisiana
Study site
Southfield, Michigan
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Spartanburg, South Carolina
Study site
St Louis, Missouri
Study site
Tacoma, Washington
Study site
Toledo, Ohio
Study site
Tyler, Texas
Study site
Winchester, Virginia
Study site
Winston-Salem, North Carolina
Australia15 sites
Study site
Box Hill, Victoria
Study site
Cairns, Queensland
Study site
Camperdown, New South Wales
Study site
Footscray, Victoria, 3011
Study site
Garran, Australian Capital Territory, 2605
Study site
Heidelburg, Victoria, 3084
Study site
Hobart, Tasmania
Study site
Kingswood, New South Wales
Study site
Launceston, Tasmania
Study site
Nambour, Queensland
Study site
Nedlands, Western Australia, 6009
Study site
Parkville, Victoria, 3050
Study site
Perth, Western Australia
Study site
Southport, Queensland, 4215
Study site
Woodville, South Australia
Canada13 sites
Study site
Calgary, Alberta
Study site
Edmonton, Alberta
Study site
Greenfield Park, Quebec
Study site
Hamilton, Ontario
Study site
Kingston, Ontario
Study site
Montreal, Quebec
Study site
New Westminster, British Columbia
Study site
Ottawa, Ontario
Study site
Surrey, British Columbia
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Victoria, British Columbia
Study site
Winnipeg, Manitoba
Belgium10 sites
Study site
Bouge
Study site
Braine-l'Alleud
Study site
Brussels, Jette
Study site
Brussels
Study site
Ghent
Study site
Liège
Study site
Mons
Study site
Ottignies
Study site
Seraing
Study site
Yvoir
Brazil10 sites
Study site
Campinas, São Paulo
Study site
Curitiba, Paraná
Study site
Florianópolis, Santa Catarina
Study site
Fortaleza, Ceará
Study site
Pelotas, Rio Grande do Sul
Study site
Porto Alegre, Rio Grande do Sul
Study site
Recife, Pernambuco
Belgium
Salvador, Estado de Bahia
Study site
Salvador, Estado de Bahia
Study site
São José do Rio Preto, São Paulo
France9 sites
Study site
Argenteuil
Study site
Belfort
Study site
Besançon
Study site
La Roche Sur Yoon
Study site
Limoges
Study site
Paris
Study site
Pierre-Bénite
Study site
Saint-Michel
Study site
Tours
South Africa6 sites
Study site
Bloemfontein
Study site
Centurion
Study site
Kimberley
Study site
KwaKhangela, Durban
Study site
Parktown, Johannesburg
Study site
Parktown West
South Korea6 sites
Study site
Gyeonggi-do
Study site
Gyunggi
Study site
Namdong-gu, Incheon
Study site
Seoul
Study site
Suwon
Study site
Wŏnju, Gangwon-do
Malaysia5 sites
Study site
George Town
Study site
Johor Bahru
Study site
Kota Bharu Kelantan
Study site
Kuala Lumpar
Study site
Kuala Selangor
Argentina4 sites
Study site
Capital Federal
Study site
Mar del Plata, Buenos Aires
Study site
Tandil, Buenos Aires
Study site
Tres de Febrero, Buenos Aires
New Zealand4 sites
Study site
Christchurch
Study site
Grafton, Auckland
Study site
Hastings
Study site
Otahuhu, Auckland
Spain4 sites
Study site
Madrid
Study site
Palma de Mallorca
Study site
Sabadell, Barcelona
Study site
Santiago de Compostela
Germany3 sites
Study site
Lübeck
Study site
München, 81545
Study site
Regensburg
Netherlands3 sites
Study site
's-Hertogenbosch
Study site
Rotterdam
Study site
Utrecht
United Kingdom3 sites
Study site
Glasgow
Study site
Livingston
Study site
London
About this study
Official title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.
- Conditions
- Pneumonia
- Being tested
- Tifacogin
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TifacoginDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effect of tifacogin vs placebo administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2004 (estimated)
- Study startMay 2004
- Primary completionJul 2008
- Study completionJul 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 Novartis PharmaceuticalsThe 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
- Double blind
- Enrolment
- 2,136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084071
- Sponsor's protocol ID
- CTFP561A2308
- Status last verified
- Jul 2012
- First submitted
- 4 Jun 2004
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Laterre PF, Opal SM, Abraham E, LaRosa SP, Creasey AA, Xie F, Poole L, Wunderink RG. A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia. Crit Care. 2009;13(2):R36. doi: 10.1186/cc7747. Epub 2009 Mar 15.
PubMed 19284881
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT00084071
- Acronym / sponsor ID
- CTFP561A2308
- Conditions
- Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,136 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Jun 2004 (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.
The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence
- Pneumonia of sufficient severity to require ICU admission and management
Key exclusion criteria (5 listed)
- Pregnancy
- Weight over 150 kg
- Patients at increased risk of bleeding
- Treatment with drotrecogin alfa or anticipated need for drotrecogin alfa
- Treatment with heparin or anticipated need for heparin
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 |
|---|---|---|
| Tifacogin | Drug | – |
Primary outcome
Compare the effect of tifacogin vs placebo administration.
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 19 Dec 2020.
- Derived from this study: PubMed 19284881Laterre PF, Opal SM, Abraham E, LaRosa SP, Creasey AA, Xie F, Poole L, Wunderink RG. A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia. Crit Care. 2009;13(2):R36. doi: 10.1186/cc7747. Epub 2009 Mar 15.
- Results for CTFP561A2308 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
Novartis study director
Novartis
150 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tifacogin in people with Pneumonia, run by Novartis Pharmaceuticals at 150 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 150 sites in United States, Australia, Canada, Belgium, Brazil and 13 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?
Compare the effect of tifacogin vs placebo administration.. 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 NCT00084071, 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 19 Dec 2020.