Study Evaluating the Safety and Efficacy of a Once-Daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections

Condition(s) targeted: Bacterial Infections; Diabetic Foot; Osteomyelitis

Intervention: Tigecycline (Drug); Ertapenem (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Hungary, WPBUMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Spain, infomed@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Taiwan, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For South Africa, ZAFinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Canada, clintrialparticipation@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Australia, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Austria, WPVIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Croatia, WPBUMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Latvia, WPVIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Lithuania, WPVIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Romania, WVPIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Argentina, Scheima@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Brazil, xavierl@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Chile, scheima@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Mexico, gomezzlj@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Sweden, MedInfoNord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, medinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Denmark, medinfonord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Estonia, WVPMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Finland, MedInfoNord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For UK/Great Britian: ukmedinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Switzerland, med@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Greece, decresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, descresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Russia, WVPIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Turkey, Erisc@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Ukraine, WVPIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For China, medinfo@wyeth.com

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

This purpose of this study is to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical response rate (cure/failure rate) 14 to 21 days after the last dose of study antibiotic(s) for participants with diabetic foot infections without osteomyelitis.

Secondary outcome: Microbiologic efficacy, microbiologic susceptibility data, health care resource utilization, pharmacokinetic profile of 150 mg once-daily dose, clinical response rate for diabetic foot infections with osteomyelitis

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Trial Manager, Email: clintrialparticipation@wyeth.com

Cordoba 5000, Argentina; Not yet recruiting

Ciudad Autonoma de Buenos Aires 1181, Argentina; Not yet recruiting

Buenos Aires 1180, Argentina; Not yet recruiting

Buenos Aires 1428, Argentina; Not yet recruiting

Cordoba 5004, Argentina; Not yet recruiting

Mendoza 5500, Argentina; Not yet recruiting

Cordoba 5016, Argentina; Not yet recruiting

Buenos Aires CP C1180 AAX, Argentina; Recruiting

Cordoba CP 5000, Argentina; Recruiting

Cordoba 5004, Argentina; Recruiting

Cordoba CP 5016, Argentina; Recruiting

Buenos Aires CP 1428, Argentina; Not yet recruiting

Wien 1100, Austria; Recruiting

Graz 8036, Austria; Withdrawn

Bruxelles 1070, Belgium; Not yet recruiting

Pellenberg 3212, Belgium; Recruiting

Bornem 2880, Belgium; Not yet recruiting

Bruxelles 1080, Belgium; Not yet recruiting

Brussel 1090, Belgium; Not yet recruiting

Belo Horizonte 04012-909, Brazil; Withdrawn

Porto Alegre 90020-090, Brazil; Withdrawn

Fortaleza 60414-021, Brazil; Withdrawn

Fortaleza 60430-350, Brazil; Withdrawn

Brasilia 72119-900, Brazil; Withdrawn

Curitiba 80810-040, Brazil; Withdrawn

Sorocaba 18030-210, Brazil; Withdrawn

Goiania 74043-011, Brazil; Withdrawn

Sao Jose do Rio Preto 15090-000, Brazil; Withdrawn

Sao Paulo 05422-970, Brazil; Not yet recruiting

Rio de Janeiro 20211-340, Brazil; Not yet recruiting

Sao Paulo 04020-060, Brazil; Withdrawn

Santiago, Chile; Recruiting

Valdivia, Chile; Recruiting

Beijing 100101, China; Not yet recruiting

Beijing 100730, China; Recruiting

Guangzhou 510120, China; Not yet recruiting

Tianjin 300070, China; Not yet recruiting

Bogota, Colombia; Not yet recruiting

Bogota NAP, Colombia; Not yet recruiting

Zagreb 10000, Croatia; Recruiting

Zadar 23 000, Croatia; Recruiting

Zagreb 10 000, Croatia; Recruiting

Odense 5000, Denmark; Not yet recruiting

Tallinn 13419, Estonia; Recruiting

Tartu 50410, Estonia; Not yet recruiting

Tartu 51014, Estonia; Recruiting

Turku 20520, Finland; Recruiting

Tampere, Finland; Withdrawn

Kuopio 70210, Finland; Not yet recruiting

Nimes 30900, France; Withdrawn

Tourcoing 59200, France; Terminated

Strasbourg 67000, France; Terminated

Frankfurt 60318, Germany; Withdrawn

Rio-Patras 265 04, Greece; Not yet recruiting

Holargos, Athens 11527, Greece; Not yet recruiting

Athens 106 76, Greece; Not yet recruiting

Gyor 9024, Hungary; Recruiting

Szekesfehervar 8000, Hungary; Recruiting

Budapest 1082, Hungary; Recruiting

Kistarcsa 2143, Hungary; Not yet recruiting

Debrecen 4012, Hungary; Not yet recruiting

Budapest 1076, Hungary; Terminated

Budapest H-1027, Hungary; Recruiting

Ancona 60100, Italy; Withdrawn

Pisa 56124, Italy; Not yet recruiting

Abano terme (PD) 35031, Italy; Not yet recruiting

Rome 133, Italy; Not yet recruiting

Seoul 138-736, Korea, Republic of; Recruiting

Seoul 136-075, Korea, Republic of; Recruiting

Gyeonggi-do 425-801, Korea, Republic of; Recruiting

Seoul 135-710, Korea, Republic of; Recruiting

Riga 1002, Latvia; Recruiting

Riga 1001, Latvia; Recruiting

Riga 1038, Latvia; Recruiting

Liepaja 3401, Latvia; Not yet recruiting

Riga LV-1001, Latvia; Terminated

Riga LV-1038, Latvia; Not yet recruiting

Vilnius 10207, Lithuania; Not yet recruiting

Kaunas 47144, Lithuania; Not yet recruiting

Vilnius 10207, Lithuania; Recruiting

Klaipeda 92288, Lithuania; Recruiting

Siauliai 76231, Lithuania; Not yet recruiting

Panevezys 35144, Lithuania; Not yet recruiting

Kaunas 50009, Lithuania; Recruiting

Kaunas LT-50009, Lithuania; Recruiting

Vilnius LT-10207, Lithuania; Recruiting

Klaipeda 92288, Lithuania; Not yet recruiting

San Luis Potosi 78210, Mexico; Not yet recruiting

Veracruz 91910, Mexico; Recruiting

Durango 34000, Mexico; Recruiting

San Luis Potosi CP 78210, Mexico; Not yet recruiting

Mendoza CP 5500, Mexico; Recruiting

Santa Fe CP 2000, Mexico; Recruiting

Panama 907, Panama; Not yet recruiting

Lima Lima 31, Peru; Not yet recruiting

Lima Lima 11, Peru; Not yet recruiting

Gdansk 80-211, Poland; Not yet recruiting

Wroclaw 50-326, Poland; Not yet recruiting

Warsaw 02-097, Poland; Recruiting

Lodz 91-425, Poland; Recruiting

Bielsko-Biala 43-300, Poland; Not yet recruiting

Cieszyn 43-400, Poland; Not yet recruiting

Lisboa 1169-050, Portugal; Not yet recruiting

Lisbon 1495-005, Portugal; Not yet recruiting

Bucharest 20475, Romania; Recruiting

Bacau 600114, Romania; Recruiting

Lasi 700111, Romania; Recruiting

Cluj-Napoca 400006, Romania; Recruiting

Smolensk 214019, Russian Federation; Recruiting

St. Petersburg 198095, Russian Federation; Recruiting

Moscow 129327, Russian Federation; Recruiting

Kemerovo 650061, Russian Federation; Recruiting

Yaroslavl, Russian Federation; Recruiting

Moscow 129110, Russian Federation; Recruiting

Moscow 113152, Russian Federation; Not yet recruiting

Moscow 111020, Russian Federation; Recruiting

Novosibirsk 630117, Russian Federation; Recruiting

Chelyabinsk 454 021, Russian Federation; Recruiting

Nizhny Novgorod 603076, Russian Federation; Not yet recruiting

Omsk 644021, Russian Federation; Not yet recruiting

Moscow 127486, Russian Federation; Not yet recruiting

Ekaterinburg 620109, Russian Federation; Not yet recruiting

Moscow 127299, Russian Federation; Not yet recruiting

St. Petersburg 196247, Russian Federation; Not yet recruiting

Nizhniy Novgorod 603005, Russian Federation; Not yet recruiting

Bratislava 813 69, Slovakia; Recruiting

Nitra 949 01, Slovakia; Recruiting

Lubochna 034 91, Slovakia; Not yet recruiting

Martin 036 59, Slovakia; Not yet recruiting

Nove Zamky 9401, Slovakia; Not yet recruiting

Banska Bystrica 975 17, Slovakia; Recruiting

Banska.Bysterica 97517, Slovakia; Recruiting

Granada 18012, Spain; Recruiting

Getafe Madrid 28905, Spain; Recruiting

Madrid 28007, Spain; Not yet recruiting

Palma de Mallorca 7198, Spain; Not yet recruiting

Barcelona 8907, Spain; Not yet recruiting

Malmo 205 02, Sweden; Withdrawn

Uppsala 751 85, Sweden; Not yet recruiting

Huddinge 141 86, Sweden; Not yet recruiting

Copenhagen 2400, Sweden; Not yet recruiting

Uppsala SE-751 85, Sweden; Withdrawn

Basel CH 4031, Switzerland; Not yet recruiting

Geneva CH 1211, Switzerland; Recruiting

Tainan, Taiwan; Recruiting

Taoyuan Hsien, Taiwan; Recruiting

Capa-Istanbul 34390, Turkey; Not yet recruiting

Istanbul 34303, Turkey; Not yet recruiting

Adana 1330, Turkey; Not yet recruiting

Kyiv 2175, Ukraine; Not yet recruiting

Vinnytsia 21010, Ukraine; Recruiting

Lviv 79010, Ukraine; Recruiting

Cherkassy 18009, Ukraine; Terminated

Zaporozhye 69600, Ukraine; Recruiting

Kiev 2125, Ukraine; Recruiting

Dnepropetrovsk 49001, Ukraine; Not yet recruiting

Kyiv 02175, Ukraine; Recruiting

Birmingham B95SS, United Kingdom; Recruiting

Oxford OX3 7LD, United Kingdom; Not yet recruiting

London SE5 9RS, United Kingdom; Not yet recruiting

Vancouver, British Columbia V6Z 1Y6, Canada; Not yet recruiting

Loma Hermosa, Buenos Aires 1657, Argentina; Not yet recruiting

Ciudadela, 3 de Febrero, Buenos Aires 1702, Argentina; Not yet recruiting

Chivilcoy, Buenos Aires 6620, Argentina; Recruiting

La Plata, Buenos Aires 1072, Argentina; Recruiting

Moron, Buenos Aires 1072, Argentina; Not yet recruiting

Merlo, Buenos Aires 1722, Argentina; Recruiting

Loma Hermosa, Buenos Aires CP 1657, Argentina; Recruiting

Ciudadela, 3 de Febrero, Buenos Aires CP 1702, Argentina; Recruiting

La Plata, Buenos Aires CP 1900, Argentina; Recruiting

Northridge, California 91326, United States; Not yet recruiting

San Francisco, California 94115, United States; Not yet recruiting

Sylmar, California 91342, United States; Recruiting

Los Angeles, California 91342, United States; Not yet recruiting

Los Angeles, California 90010, United States; Not yet recruiting

Torrance, California 90502, United States; Not yet recruiting

Port Elizabeth, Eastern Cape 6014, South Africa; Recruiting

Parana, Entre Rios 3100, Argentina; Not yet recruiting

Paraná, Entre Ríos CP 3100, Argentina; Not yet recruiting

Orlando, Florida 32806, United States; Recruiting

Orlando, Florida 32801, United States; Active, not recruiting

West Palm Beach, Florida 33407, United States; Recruiting

Pensacola, Florida 32501, United States; Not yet recruiting

Benoni, Gauteng 1501, South Africa; Recruiting

Pretoria, Gauteng 84, South Africa; Recruiting

Colonia El Ritiro, Guadalajara 44280, Mexico; Recruiting

Baroda, Gujarat 390001, India; Recruiting

Honolulu, Hawaii 96814, United States; Not yet recruiting

Harbin, Heilongjiang 150086, China; Not yet recruiting

Giessen, Hessen 35392, Germany; Not yet recruiting

Kohtla Jarve, Ida Virumaa 30322, Estonia; Recruiting

North Chicago, Illinois 60064, United States; Recruiting

Springfield, Illinois 62701, United States; Recruiting

Springfield, Illinois 62791, United States; Recruiting

Evanston, Illinois 60201, United States; Not yet recruiting

Chicago, Illinois 60637, United States; Not yet recruiting

Guadalajara, Jalisco 44260, Mexico; Not yet recruiting

Bangalore, Karnataka 560002, India; Recruiting

Wishaw, Lanarkshire ML2 0DP, United Kingdom; Recruiting

Wishaw, Lanarkshire ML2 0DP, United Kingdom; Not yet recruiting

Pune, Maharashtra 411001, India; Recruiting

Winnipeg, Manitoba R3A 1R9, Canada; Recruiting

Baltimore, Maryland 21224, United States; Not yet recruiting

Boston, Massachusetts 02215, United States; Not yet recruiting

Tunuyan, Mendoza 5560, Argentina; Not yet recruiting

Somers Point, New Jersey 08244, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Not yet recruiting

Rheine, North Rhine-Westphalia 48431, Germany; Recruiting

Bochum, North Rhine-Westphalia 44789, Germany; Recruiting

Gelsenkirchen, North Rhine-Westphalia 45891, Germany; Not yet recruiting

Bochum, North Rhine-Westphalia 44789, Germany; Not yet recruiting

Muenster, Northrhien-Westphalia 48129, Germany; Not yet recruiting

Toledo, Ohio 43614, United States; Not yet recruiting

Lima, Ohio 45801, United States; Recruiting

Ottawa, Ontario K1H 8L6, Canada; Not yet recruiting

Hamilton, Ontario L8V 1C3, Canada; Not yet recruiting

West Reading, Pennsylvania 19610, United States; Not yet recruiting

La Plata, Provincia de Buenos Aires 1900, Argentina; Not yet recruiting

Mar del Plata, Provincia de Buenos Aires 7602, Argentina; Not yet recruiting

San Miguel de Tucuman, Provincia de Tucuman 4000, Argentina; Recruiting

Chicoutimi, Quebec G7H 5H6, Canada; Recruiting

Montreal, Quebec H3T 1E2, Canada; Not yet recruiting

Sherbrooke, Quebec J1H 5N4, Canada; Not yet recruiting

Trois-Rivieres, Quebec G8Z 3R9, Canada; Recruiting

Jaipur, Rajasthan 302001, India; Recruiting

Rosario, Santa Fe 2000, Argentina; Not yet recruiting

Hermosillo, Sonora 83190, Mexico; Not yet recruiting

Columbia, South Carolina 29203, United States; Not yet recruiting

Dallas, Texas 75203, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Melbourne, Victoria 3128, Australia; Recruiting

Melbourne, Victoria 3050, Australia; Recruiting

Birmingham, West Midlands B29 6JD, United Kingdom; Not yet recruiting

Starting date: September 2006
Ending date: August 2009
Last updated: April 25, 2008