Clinical trial NCT00366249: 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.
Official title: A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Diabetic Foot
Osteomyelitis
Keywords: Diabetic foot infection
Osteomyelitis
Diabetes Complications
Foot ulcer
Skin infection
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 1061
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.


Eligibility criteria: Main inclusion criteria:

* Men and women aged 18 or older with diabetes and a qualifying foot infection. People with evidence of a diabetic foot infection with osteomyelitis may qualify for the osteomyelitis substudy arm.

Main exclusion criteria:

* People with additional significant disease, infection with resistant pathogens, contraindication, or hypersensitivity to any test article or related antibiotic.

Primary outcomes:
measure: Number of Patients With Clinical Response of Cure Vs. Failure.
timeFrame: Test of cure visit (TOC): Assessed at least 12 days post last dose
measure: Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.
timeFrame: Test of cure visit (TOC): Assessed at least 12 days post last dose
Secondary outcomes:
measure: Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.
timeFrame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
measure: Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.
timeFrame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
measure: Number of Patients With Microbiologic Response of Eradication.
timeFrame: Test of cure visit (TOC): Assessed at least 12 days post last dose
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Northridge
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Torrance
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Somers Point
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Lima
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: West Reading
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Chivilcoy
country: Argentina
state: Buenos Aires
city: Ciudadela, 3 de Febrero
country: Argentina
state: Buenos Aires
city: Ciudadela, 3 de Febrero
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: Loma Hermosa
country: Argentina
state: Buenos Aires
city: Loma Hermosa
country: Argentina
state: Buenos Aires
city: Merlo
country: Argentina
state: Buenos Aires
city: Moron
country: Argentina
state: Buenos Aires
city: Parana
country: Argentina
state: Entre Rios
city: Paraná
country: Argentina
state: Entre Ríos
city: Tunuyan
country: Argentina
state: Mendoza
city: La Plata
country: Argentina
state: Provincia de Buenos Aires
city: Mar del Plata
country: Argentina
state: Provincia de Buenos Aires
city: San Miguel de Tucuman
country: Argentina
state: Provincia de Tucuman
city: Rosario
country: Argentina
state: Santa Fe
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma de Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Cordoba
country: Argentina
city: Cordoba
country: Argentina
city: Cordoba
country: Argentina
city: Cordoba
country: Argentina
city: Mendoza
country: Argentina
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Wien
country: Austria
city: Bornem
country: Belgium
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Pellenberg
country: Belgium
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Valdivia
country: Chile
city: Harbin
country: China
state: Heilongjiang
city: Beijing
country: China
city: Beijing
country: China
city: Guangzhou
country: China
city: Tianjin
country: China
city: Bogota
country: Colombia
city: Bogota
country: Colombia
city: Zadar
country: Croatia
city: Zagreb
country: Croatia
city: Zagreb
country: Croatia
city: Odense
country: Denmark
city: Kohtla Jarve
country: Estonia
state: Ida Virumaa
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Kuopio
country: Finland
city: Turku
country: Finland
city: Strasbourg
country: France
city: Tourcoing
country: France
city: Giessen
country: Germany
state: Hessen
city: Bochum
country: Germany
state: North Rhine-Westphalia
city: Gelsenkirchen
country: Germany
state: North Rhine-Westphalia
city: Rheine
country: Germany
state: North Rhine-Westphalia
city: Muenster
country: Germany
state: Northrhien-Westphalia
city: Athens
country: Greece
city: Holargos, Athens
country: Greece
city: Rio-Patras
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Kistarcsa
country: Hungary
city: Szekesfehervar
country: Hungary
city: Baroda
country: India
state: Gujarat
city: Bangalore
country: India
state: Karnataka
city: Pune
country: India
state: Maharashtra
city: Jaipur
country: India
state: Rajasthan
city: Abano terme (PD)
country: Italy
city: Pisa
country: Italy
city: Rome
country: Italy
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Panevezys
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Colonia El Ritiro
country: Mexico
state: Guadalajara
city: Guadalajara
country: Mexico
state: Jalisco
city: Hermosillo
country: Mexico
state: Sonora
city: Durango
country: Mexico
city: Mendoza
country: Mexico
city: San Luis Potosi
country: Mexico
city: San Luis Potosi
country: Mexico
city: Santa Fe
country: Mexico
city: Veracruz
country: Mexico
city: Panama
country: Panama
city: Lima
country: Peru
city: Lima
country: Peru
city: Bielsko-Biala
country: Poland
city: Cieszyn
country: Poland
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Lisboa
country: Portugal
city: Lisbon
country: Portugal
city: Bacau
country: Romania
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Lasi
country: Romania
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Banska Bystrica
country: Slovakia
city: Banska.Bysterica
country: Slovakia
city: Bratislava
country: Slovakia
city: Lubochna
country: Slovakia
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Zamky
country: Slovakia
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Benoni
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Barcelona
country: Spain
city: Getafe Madrid
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Copenhagen
country: Sweden
city: Huddinge
country: Sweden
city: Uppsala
country: Sweden
city: Basel
country: Switzerland
city: Geneva
country: Switzerland
city: Tainan
country: Taiwan
city: Taoyuan Hsien
country: Taiwan
city: Adana
country: Turkey
city: Capa-Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Cherkassy
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporozhye
country: Ukraine
city: Wishaw
country: United Kingdom
state: Lanarkshire
city: Birmingham
country: United Kingdom
state: West Midlands
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Taiwan, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa, ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Canada, clintrialparticipation@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Croatia, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Latvia, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Lithuania, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Romania, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Argentina, Scheima@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Brazil, xavierl@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Chile, scheima@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico, gomezzlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Sweden, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Denmark, medinfonord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Estonia, WVPMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Finland, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK/Great Britian: ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Switzerland, med@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Greece, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Russia, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Turkey, Erisc@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Ukraine, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For China, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.