Clinical trial NCT00084071: Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia
Official title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-06-08
Enrollment: 2136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence
* Pneumonia of sufficient severity to require ICU admission and management

Exclusion Criteria:

* 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

Primary outcomes:
measure: Compare the effect of tifacogin vs placebo administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Bay Pines
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Muncie
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Cumberland
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Reno
country: United States
state: Nevada
city: Buffalo
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Pawtucket
country: United States
state: Rhode Island
city: Providence
country: United States
state: Rhode Island
city: Spartanburg
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Mar del Plata
country: Argentina
state: Buenos Aires
city: Tandil
country: Argentina
state: Buenos Aires
city: Tres De Febrero
country: Argentina
state: Buenos Aires
city: Capital Federal
country: Argentina
city: Garran
country: Australia
state: Australian Capital Territory
city: Camperdown
country: Australia
state: New South Wales
city: Kingswood
country: Australia
state: New South Wales
city: Cairns
country: Australia
state: Queensland
city: Nambour
country: Australia
state: Queensland
city: Southport
country: Australia
state: Queensland
city: Woodville
country: Australia
state: South Australia
city: Hobart
country: Australia
state: Tasmania
city: Launceston
country: Australia
state: Tasmania
city: Box Hill
country: Australia
state: Victoria
city: Footscray
country: Australia
state: Victoria
city: Heidelburg
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Perth
country: Australia
state: Western Australia
city: Brussels
country: Belgium
state: Jette
city: Bouge
country: Belgium
city: Braine l'Alleud
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Mons
country: Belgium
city: Ottignies
country: Belgium
city: Seraing
country: Belgium
city: Yvoir
country: Belgium
city: Salvador
country: Brazil
facility: Belgium
state: BA
city: Salvador
country: Brazil
state: BA
city: Fortaleza
country: Brazil
state: CE
city: Recife
country: Brazil
state: PE
city: Curitiba
country: Brazil
state: PR
city: Pelotas
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Florianopolis
country: Brazil
state: SC
city: Campinas
country: Brazil
state: SP
city: Sao Jose do Rio Preto
country: Brazil
state: SP
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: New Westminster
country: Canada
state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Santiago de Chile
country: Chile
city: Temuco
country: Chile
city: Argenteuil
country: France
city: Belfort
country: France
city: Besancon
country: France
city: La Roche Sur Yoon
country: France
city: Limoges
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Saint Michel
country: France
city: Tours
country: France
city: Luebeck
country: Germany
city: Munchen
country: Germany
city: Regensburg
country: Germany
city: Wonju
country: Korea, Republic of
state: Gangwon-do
city: Namdong-gu
country: Korea, Republic of
state: Incheon
city: Gyeonggi-Do
country: Korea, Republic of
city: Gyunggi
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Johor Bahru
country: Malaysia
city: Kota Bharu Kelantan
country: Malaysia
city: Kuala Lumpar
country: Malaysia
city: Penang
country: Malaysia
city: Selangor
country: Malaysia
city: Hertogenbosch
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Grafton
country: New Zealand
state: Auckland
city: Otahuhu
country: New Zealand
state: Auckland
city: Christchurch
country: New Zealand
city: Hastings
country: New Zealand
city: Lima
country: Peru
city: Singapore
country: Singapore
city: Congella
country: South Africa
state: Durban
city: Parktown
country: South Africa
state: Johannesburg
city: Bloemfontein
country: South Africa
city: Centurion
country: South Africa
city: Kimberley
country: South Africa
city: Parktown West
country: South Africa
city: Sabadell
country: Spain
state: Barcelona
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Santiago de Compostela
country: Spain
city: Glasgow
country: United Kingdom
city: Livingston
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: 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.