Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00084071




Registration number
NCT00084071
Ethics application status
Date submitted
4/06/2004
Date registered
8/06/2004
Date last updated
19/12/2020

Titles & IDs
Public title
Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia
Scientific title
Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
Secondary ID [1] 0 0
CTFP561A2308
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 - Tifacogin

Treatment: Drugs: Tifacogin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare the effect of tifacogin vs placebo administration.
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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?



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
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
2136
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Kingswood
Recruitment hospital [4] 0 0
- Cairns
Recruitment hospital [5] 0 0
- Nambour
Recruitment hospital [6] 0 0
- Southport
Recruitment hospital [7] 0 0
- Woodville
Recruitment hospital [8] 0 0
- Hobart
Recruitment hospital [9] 0 0
- Launceston
Recruitment hospital [10] 0 0
- Box Hill
Recruitment hospital [11] 0 0
- Footscray
Recruitment hospital [12] 0 0
- Heidelburg
Recruitment hospital [13] 0 0
- Parkville
Recruitment hospital [14] 0 0
- Nedlands
Recruitment hospital [15] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- Nambour
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
- Woodville
Recruitment postcode(s) [8] 0 0
- Hobart
Recruitment postcode(s) [9] 0 0
- Launceston
Recruitment postcode(s) [10] 0 0
- Box Hill
Recruitment postcode(s) [11] 0 0
3011 - Footscray
Recruitment postcode(s) [12] 0 0
3084 - Heidelburg
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment postcode(s) [15] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Capital Federal
Country [30] 0 0
Belgium
State/province [30] 0 0
Jette
Country [31] 0 0
Belgium
State/province [31] 0 0
Bouge
Country [32] 0 0
Belgium
State/province [32] 0 0
Braine l'Alleud
Country [33] 0 0
Belgium
State/province [33] 0 0
Brussels
Country [34] 0 0
Belgium
State/province [34] 0 0
Gent
Country [35] 0 0
Belgium
State/province [35] 0 0
Liege
Country [36] 0 0
Belgium
State/province [36] 0 0
Mons
Country [37] 0 0
Belgium
State/province [37] 0 0
Ottignies
Country [38] 0 0
Belgium
State/province [38] 0 0
Seraing
Country [39] 0 0
Belgium
State/province [39] 0 0
Yvoir
Country [40] 0 0
Brazil
State/province [40] 0 0
BA
Country [41] 0 0
Brazil
State/province [41] 0 0
CE
Country [42] 0 0
Brazil
State/province [42] 0 0
PE
Country [43] 0 0
Brazil
State/province [43] 0 0
PR
Country [44] 0 0
Brazil
State/province [44] 0 0
RS
Country [45] 0 0
Brazil
State/province [45] 0 0
SC
Country [46] 0 0
Brazil
State/province [46] 0 0
SP
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Manitoba
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Chile
State/province [52] 0 0
Santiago de Chile
Country [53] 0 0
Chile
State/province [53] 0 0
Temuco
Country [54] 0 0
France
State/province [54] 0 0
Argenteuil
Country [55] 0 0
France
State/province [55] 0 0
Belfort
Country [56] 0 0
France
State/province [56] 0 0
Besancon
Country [57] 0 0
France
State/province [57] 0 0
La Roche Sur Yoon
Country [58] 0 0
France
State/province [58] 0 0
Limoges
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Pierre Benite
Country [61] 0 0
France
State/province [61] 0 0
Saint Michel
Country [62] 0 0
France
State/province [62] 0 0
Tours
Country [63] 0 0
Germany
State/province [63] 0 0
Luebeck
Country [64] 0 0
Germany
State/province [64] 0 0
Munchen
Country [65] 0 0
Germany
State/province [65] 0 0
Regensburg
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Gangwon-do
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Incheon
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Gyeonggi-Do
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Gyunggi
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Seoul
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Suwon
Country [72] 0 0
Malaysia
State/province [72] 0 0
Johor Bahru
Country [73] 0 0
Malaysia
State/province [73] 0 0
Kota Bharu Kelantan
Country [74] 0 0
Malaysia
State/province [74] 0 0
Kuala Lumpar
Country [75] 0 0
Malaysia
State/province [75] 0 0
Penang
Country [76] 0 0
Malaysia
State/province [76] 0 0
Selangor
Country [77] 0 0
Netherlands
State/province [77] 0 0
Hertogenbosch
Country [78] 0 0
Netherlands
State/province [78] 0 0
Rotterdam
Country [79] 0 0
Netherlands
State/province [79] 0 0
Utrecht
Country [80] 0 0
New Zealand
State/province [80] 0 0
Auckland
Country [81] 0 0
New Zealand
State/province [81] 0 0
Christchurch
Country [82] 0 0
New Zealand
State/province [82] 0 0
Hastings
Country [83] 0 0
Peru
State/province [83] 0 0
Lima
Country [84] 0 0
Singapore
State/province [84] 0 0
Singapore
Country [85] 0 0
South Africa
State/province [85] 0 0
Durban
Country [86] 0 0
South Africa
State/province [86] 0 0
Johannesburg
Country [87] 0 0
South Africa
State/province [87] 0 0
Bloemfontein
Country [88] 0 0
South Africa
State/province [88] 0 0
Centurion
Country [89] 0 0
South Africa
State/province [89] 0 0
Kimberley
Country [90] 0 0
South Africa
State/province [90] 0 0
Parktown West
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
Country [92] 0 0
Spain
State/province [92] 0 0
Madrid
Country [93] 0 0
Spain
State/province [93] 0 0
Palma de Mallorca
Country [94] 0 0
Spain
State/province [94] 0 0
Santiago de Compostela
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Glasgow
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Livingston
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00084071
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Novartis
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/ct2/show/NCT00084071