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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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- Nambour
Recruitment hospital [6] 0 0
- Southport
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- 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
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United States of America
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Alabama
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California
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Hastings
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Lima
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Centurion
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Kimberley
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Parktown West
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Spain
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Barcelona
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Madrid
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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/study/NCT00084071
Trial related presentations / 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.
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/study/NCT00084071