Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00084071
• Collaborator: (none)
• Enrollment: 2,136
• Locations: 150
• Duration (Months): 50
• Patients Per Site: 14.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: Tifacogin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 2136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Outcome Measures

Primary Outcome Measures

1. Compare the effect of tifacogin vs placebo administration. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mobile	Alabama	United States
2		Loma Linda	California	United States
3		Los Angeles	California	United States
4		Orange	California	United States
5		Sacramento	California	United States
6		San Diego	California	United States
7		San Jose	California	United States
8		Denver	Colorado	United States
9		Farmington	Connecticut	United States
10		New Haven	Connecticut	United States
11		Newark	Delaware	United States
12		Bay Pines	Florida	United States	33744
13		Clearwater	Florida	United States
14		Fort Lauderdale	Florida	United States
15		Jacksonville	Florida	United States
16		Atlanta	Georgia	United States
17		Conyers	Georgia	United States
18		Decatur	Georgia	United States
19		Chicago	Illinois	United States
20		Oak Park	Illinois	United States
21		Muncie	Indiana	United States
22		New Albany	Indiana	United States
23		Shreveport	Louisiana	United States
24		Baltimore	Maryland	United States
25		Cumberland	Maryland	United States
26		Detroit	Michigan	United States
27		Southfield	Michigan	United States
28		Saint Louis	Missouri	United States
29		Butte	Montana	United States
30		Reno	Nevada	United States
31		Buffalo	New York	United States
32		Johnson City	New York	United States
33		Greensboro	North Carolina	United States
34		Winston-Salem	North Carolina	United States
35		Cincinnati	Ohio	United States
36		Columbus	Ohio	United States
37		Toledo	Ohio	United States
38		Oklahoma City	Oklahoma	United States
39		Allentown	Pennsylvania	United States
40		Pawtucket	Rhode Island	United States
41		Providence	Rhode Island	United States
42		Spartanburg	South Carolina	United States
43		Knoxville	Tennessee	United States
44		Dallas	Texas	United States
45		San Antonio	Texas	United States
46		Tyler	Texas	United States
47		Salt Lake City	Utah	United States
48		Norfolk	Virginia	United States
49		Winchester	Virginia	United States
50		Seattle	Washington	United States
51		Tacoma	Washington	United States
52		Mar del Plata	Buenos Aires	Argentina
53		Tandil	Buenos Aires	Argentina
54		Tres De Febrero	Buenos Aires	Argentina
55		Capital Federal		Argentina
56		Garran	Australian Capital Territory	Australia	2605
57		Camperdown	New South Wales	Australia
58		Kingswood	New South Wales	Australia
59		Cairns	Queensland	Australia
60		Nambour	Queensland	Australia
61		Southport	Queensland	Australia	4215
62		Woodville	South Australia	Australia
63		Hobart	Tasmania	Australia
64		Launceston	Tasmania	Australia
65		Box Hill	Victoria	Australia
66		Footscray	Victoria	Australia	3011
67		Heidelburg	Victoria	Australia	3084
68		Parkville	Victoria	Australia	3050
69		Nedlands	Western Australia	Australia	6009
70		Perth	Western Australia	Australia
71		Brussels	Jette	Belgium
72		Bouge		Belgium
73		Braine l'Alleud		Belgium
74		Brussels		Belgium
75		Gent		Belgium
76		Liege		Belgium
77		Mons		Belgium
78		Ottignies		Belgium
79		Seraing		Belgium
80		Yvoir		Belgium
81	Belgium	Salvador	BA	Brazil
82		Salvador	BA	Brazil
83		Fortaleza	CE	Brazil
84		Recife	PE	Brazil
85		Curitiba	PR	Brazil
86		Pelotas	RS	Brazil
87		Porto Alegre	RS	Brazil
88		Florianopolis	SC	Brazil
89		Campinas	SP	Brazil
90		Sao Jose do Rio Preto	SP	Brazil
91		Calgary	Alberta	Canada
92		Edmonton	Alberta	Canada
93		New Westminster	British Columbia	Canada
94		Surrey	British Columbia	Canada
95		Vancouver	British Columbia	Canada
96		Victoria	British Columbia	Canada
97		Winnipeg	Manitoba	Canada
98		Hamilton	Ontario	Canada
99		Kingston	Ontario	Canada
100		Ottawa	Ontario	Canada
101		Toronto	Ontario	Canada
102		Greenfield Park	Quebec	Canada
103		Montreal	Quebec	Canada
104		Santiago de Chile		Chile
105		Temuco		Chile
106		Argenteuil		France
107		Belfort		France
108		Besancon		France
109		La Roche Sur Yoon		France
110		Limoges		France
111		Paris		France
112		Pierre Benite		France
113		Saint Michel		France
114		Tours		France
115		Luebeck		Germany
116		Munchen		Germany	81545
117		Regensburg		Germany
118		Wonju	Gangwon-do	Korea, Republic of
119		Namdong-gu	Incheon	Korea, Republic of
120		Gyeonggi-Do		Korea, Republic of
121		Gyunggi		Korea, Republic of
122		Seoul		Korea, Republic of
123		Suwon		Korea, Republic of
124		Johor Bahru		Malaysia
125		Kota Bharu Kelantan		Malaysia
126		Kuala Lumpar		Malaysia
127		Penang		Malaysia
128		Selangor		Malaysia
129		Hertogenbosch		Netherlands
130		Rotterdam		Netherlands
131		Utrecht		Netherlands
132		Grafton	Auckland	New Zealand
133		Otahuhu	Auckland	New Zealand
134		Christchurch		New Zealand
135		Hastings		New Zealand
136		Lima		Peru
137		Singapore		Singapore
138		Congella	Durban	South Africa
139		Parktown	Johannesburg	South Africa
140		Bloemfontein		South Africa
141		Centurion		South Africa
142		Kimberley		South Africa
143		Parktown West		South Africa
144		Sabadell	Barcelona	Spain
145		Madrid		Spain
146		Palma de Mallorca		Spain
147		Santiago de Compostela		Spain
148		Glasgow		United Kingdom
149		Livingston		United Kingdom
150		London		United Kingdom

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for CTFP561A2308 from the Novartis Clinical Trials website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00084071
• Other Study ID Numbers: CTFP561A2308
• First Posted: Jun 8, 2004
• Last Update Posted: Dec 19, 2020
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Dec 19, 2020