Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
NCT ID: NCT00366249
Last Updated: 2010-04-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1061 participants
INTERVENTIONAL
2007-01-31
2009-03-31
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
TRIPLE
Study Groups
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A
Tigecycline
150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
B
Ertapenem
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Interventions
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Tigecycline
150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
Ertapenem
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Wyeth
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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Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
San Francisco, California, United States
Sylmar, California, United States
Torrance, California, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
West Palm Beach, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
North Chicago, Illinois, United States
Springfield, Illinois, United States
Springfield, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Somers Point, New Jersey, United States
Winston-Salem, North Carolina, United States
Lima, Ohio, United States
Toledo, Ohio, United States
West Reading, Pennsylvania, United States
Columbia, South Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Buenos Aires, Buenos Aires, Argentina
Chivilcoy, Buenos Aires, Argentina
Ciudadela, 3 de Febrero, Buenos Aires, Argentina
Ciudadela, 3 de Febrero, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Loma Hermosa, Buenos Aires, Argentina
Loma Hermosa, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Merlo, Buenos Aires, Argentina
Morón, Buenos Aires, Argentina
Paraná, Entre Ríos Province, Argentina
Paraná, Entre Ríos Province, Argentina
Tunuyán, Mendoza Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Mendoza, , Argentina
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Vienna, , Austria
Bornem, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Pellenberg, , Belgium
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Santiago, , Chile
Valdivia, , Chile
Harbin, Heilongjiang, China
Beijing, , China
Beijing, , China
Guangzhou, , China
Tianjin, , China
Bogotá, , Colombia
Bogotá, , Colombia
Zadar, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Odense, , Denmark
Kohtla-Järve, Ida-Virumaa, Estonia
Tallinn, , Estonia
Tartu, , Estonia
Tartu, , Estonia
Kuopio, , Finland
Turku, , Finland
Strasbourg, , France
Tourcoing, , France
Giessen, Hesse, Germany
Bochum, North Rhine-Westphalia, Germany
Gelsenkirchen, North Rhine-Westphalia, Germany
Rheine, North Rhine-Westphalia, Germany
Münster, Northrhien-Westphalia, Germany
Athens, , Greece
Holargos, Athens, , Greece
Rio-Patras, , Greece
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Kistarcsa, , Hungary
Székesfehérvár, , Hungary
Vadodara, Gujarat, India
Bangalore, Karnataka, India
Pune, Maharashtra, India
Jaipur, Rajasthan, India
Abano Terme (PD), , Italy
Pisa, , Italy
Rome, , Italy
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Panevezys, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Colonia El Ritiro, Guadalajara, Mexico
Guadalajara, Jalisco, Mexico
Mendoza, Mendoza, Mexico
Santa Fe, Santa Fe, Mexico
Hermosillo, Sonora, Mexico
Durango, , Mexico
San Luis Potosí City, , Mexico
San Luis Potosí City, , Mexico
Veracruz, , Mexico
Panama City, , Panama
Lima, , Peru
Lima, , Peru
Bielsko-Biala, , Poland
Cieszyn, , Poland
Gdansk, , Poland
Lodz, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Lisbon, , Portugal
Lisbon, , Portugal
Bacau, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Lasi, , Romania
Chelyabinsk, , Russia
Kemerovo, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Banska.Bysterica, , Slovakia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Ľubochňa, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
Nové Zámky, , Slovakia
Port Elizabeth, Eastern Cape, South Africa
Benoni, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Gyeonggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Getafe Madrid, , Spain
Granada, , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Copenhagen, , Sweden
Huddinge, , Sweden
Uppsala, , Sweden
Basel, , Switzerland
Geneva, , Switzerland
Tainan City, , Taiwan
Taoyuan Hsien, , Taiwan
Adana, , Turkey (Türkiye)
Capa-Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Cherkassy, , Ukraine
Dnipro, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Wishaw, Lanarkshire, United Kingdom
Birmingham, West Midlands, United Kingdom
Birmingham, , United Kingdom
London, , United Kingdom
Oxford, , United Kingdom
Countries
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References
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Lauf L, Ozsvar Z, Mitha I, Regoly-Merei J, Embil JM, Cooper A, Sabol MB, Castaing N, Dartois N, Yan J, Dukart G, Maroko R. Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis. Diagn Microbiol Infect Dis. 2014 Apr;78(4):469-80. doi: 10.1016/j.diagmicrobio.2013.12.007. Epub 2013 Dec 16.
Other Identifiers
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3074K5-319
Identifier Type: -
Identifier Source: org_study_id
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