Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
NCT ID: NCT00230971
Last Updated: 2013-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
473 participants
INTERVENTIONAL
2005-10-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
B
ceftriaxone plus metronidazole
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
Interventions
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tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
ceftriaxone plus metronidazole
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
Eligibility Criteria
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Inclusion Criteria
* Fever plus other symptoms such as nausea, vomiting, abdominal pain.
Exclusion Criteria
* Medicines that suppress the immune system
* Dialysis
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Nambour, Queensland, Australia
Cairns, , Australia
Parkville, , Australia
Shanghai, , China
Odense, , Denmark
Lahti, , Finland
Seinäjoki, , Finland
Tampere, , Finland
Marseille, , France
Nîmes, , France
Pierre-Bénite, , France
Saint-Denis, , France
Bochum, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Heidelberg, , Germany
Leipzig, , Germany
Lübeck, , Germany
Münster, , Germany
Tübingen, , Germany
Athens, , Greece
Athens, , Greece
Thessaloniki, , Greece
New Territories, , Hong Kong
Pokfulam, , Hong Kong
Hyderabad, Telangana, India
Bhopal, , India
Lucknow, , India
Mumbai, , India
New Delhi, , India
Brescia, , Italy
Genova, , Italy
Pavia, , Italy
Rome, , Italy
Udine, , Italy
Vicenza, , Italy
Manila, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Almada, , Portugal
Coimbra, , Portugal
Porto, , Portugal
Porto, , Portugal
Riyadh, , Saudi Arabia
Bellville, , South Africa
Kuilsriver, , South Africa
Parow, , South Africa
Pietermaritzburg, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Bilbao, , Spain
Madrid, , Spain
Madrid, , Spain
Murcia, , Spain
Bern, , Switzerland
Geneva, , Switzerland
Lugano, , Switzerland
Zurich, , Switzerland
Changhua, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Stockport, Cheshire, United Kingdom
Birmingham, , United Kingdom
Wigan, , United Kingdom
Countries
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References
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Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.
Other Identifiers
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3074A1-315
Identifier Type: -
Identifier Source: org_study_id
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