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.

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

Intervention: Tigecycline (Drug); Ertapenem (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
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

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.

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of Patients With Clinical Response of Cure Vs. Failure.

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.

Secondary outcome:

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.

Number of Patients With Microbiologic Response of Eradication.

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.

Buenos Aires 1180, Argentina

Buenos Aires CP C1180 AAX, Argentina

Buenos Aires CP 1428, Argentina

Buenos Aires 1428, Argentina

Ciudad Autonoma de Buenos Aires 1181, Argentina

Cordoba CP 5016, Argentina

Cordoba 5000, Argentina

Cordoba 5004, Argentina

Cordoba 5016, Argentina

Cordoba CP 5000, Argentina

Mendoza 5500, Argentina

Wien 1100, Austria

Bornem 2880, Belgium

Brussel 1090, Belgium

Bruxelles 1070, Belgium

Bruxelles 1080, Belgium

Pellenberg 3212, Belgium

Rio de Janeiro 20211-340, Brazil

Sao Paulo 05422-970, Brazil

Santiago, Chile

Valdivia, Chile

Beijing 100730, China

Beijing 100101, China

Guangzhou 510120, China

Tianjin 300070, China

Bogota, Colombia

Bogota NAP, Colombia

Zadar 23 000, Croatia

Zagreb 10 000, Croatia

Zagreb 10000, Croatia

Odense 5000, Denmark

Tallinn 13419, Estonia

Tartu 50410, Estonia

Tartu 51014, Estonia

Kuopio 70210, Finland

Turku 20520, Finland

Strasbourg 67000, France

Tourcoing 59200, France

Athens 106 76, Greece

Holargos, Athens 11527, Greece

Rio-Patras 265 04, Greece

Budapest H-1027, Hungary

Budapest 1082, Hungary

Budapest 1076, Hungary

Debrecen 4012, Hungary

Gyor 9024, Hungary

Kistarcsa 2143, Hungary

Szekesfehervar 8000, Hungary

Abano terme (PD) 35031, Italy

Pisa 56124, Italy

Rome 133, Italy

Gyeonggi-do 425-801, Korea, Republic of

Seoul 136-075, Korea, Republic of

Seoul 138-736, Korea, Republic of

Seoul 135-710, Korea, Republic of

Liepaja 3401, Latvia

Riga LV-1038, Latvia

Riga 1001, Latvia

Riga 1002, Latvia

Riga LV-1001, Latvia

Riga 1038, Latvia

Kaunas 47144, Lithuania

Kaunas 50009, Lithuania

Kaunas LT-50009, Lithuania

Klaipeda 92288, Lithuania

Panevezys 35144, Lithuania

Siauliai 76231, Lithuania

Vilnius 10207, Lithuania

Vilnius LT-10207, Lithuania

Durango 34000, Mexico

Mendoza CP 5500, Mexico

San Luis Potosi 78210, Mexico

San Luis Potosi CP 78210, Mexico

Santa Fe CP 2000, Mexico

Veracruz 91910, Mexico

Panama 907, Panama

Lima Lima 31, Peru

Lima Lima 11, Peru

Bielsko-Biala 43-300, Poland

Cieszyn 43-400, Poland

Gdansk 80-211, Poland

Lodz 91-425, Poland

Warsaw 02-097, Poland

Wroclaw 50-326, Poland

Lisboa 1169-050, Portugal

Lisbon 1495-005, Portugal

Bacau 600114, Romania

Bucharest 20475, Romania

Cluj-Napoca 400006, Romania

Lasi 700111, Romania

Chelyabinsk 454 021, Russian Federation

Ekaterinburg 620109, Russian Federation

Kemerovo 650061, Russian Federation

Moscow 129110, Russian Federation

Moscow 113152, Russian Federation

Moscow 127299, Russian Federation

Moscow 127486, Russian Federation

Moscow 129327, Russian Federation

Moscow 111020, Russian Federation

Nizhniy Novgorod 603005, Russian Federation

Nizhny Novgorod 603076, Russian Federation

Novosibirsk 630117, Russian Federation

Omsk 644021, Russian Federation

Smolensk 214019, Russian Federation

St. Petersburg 198095, Russian Federation

St. Petersburg 196247, Russian Federation

Yaroslavl, Russian Federation

Banska Bystrica 975 17, Slovakia

Banska.Bysterica 97517, Slovakia

Bratislava 813 69, Slovakia

Lubochna 034 91, Slovakia

Martin 036 59, Slovakia

Nitra 949 01, Slovakia

Nove Zamky 9401, Slovakia

Barcelona 8907, Spain

Getafe Madrid 28905, Spain

Granada 18012, Spain

Madrid 28007, Spain

Palma de Mallorca 7198, Spain

Copenhagen 2400, Sweden

Huddinge 141 86, Sweden

Uppsala 751 85, Sweden

Basel CH 4031, Switzerland

Geneva CH 1211, Switzerland

Tainan, Taiwan

Taoyuan Hsien, Taiwan

Adana 1330, Turkey

Capa-Istanbul 34390, Turkey

Istanbul 34303, Turkey

Cherkassy 18009, Ukraine

Dnepropetrovsk 49001, Ukraine

Kiev 2125, Ukraine

Kyiv 02175, Ukraine

Kyiv 2175, Ukraine

Lviv 79010, Ukraine

Vinnytsia 21010, Ukraine

Zaporozhye 69600, Ukraine

Birmingham B95SS, United Kingdom

London SE5 9RS, United Kingdom

Oxford OX3 7LD, United Kingdom

Vancouver, British Columbia V6Z 1Y6, Canada

Chivilcoy, Buenos Aires 6620, Argentina

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

Ciudadela, 3 de Febrero, Buenos Aires 1702, Argentina

La Plata, Buenos Aires 1072, Argentina

La Plata, Buenos Aires CP 1900, Argentina

Loma Hermosa, Buenos Aires 1657, Argentina

Loma Hermosa, Buenos Aires CP 1657, Argentina

Merlo, Buenos Aires 1722, Argentina

Moron, Buenos Aires 1072, Argentina

Los Angeles, California 90010, United States

Los Angeles, California 91342, United States

Northridge, California 91326, United States

San Francisco, California 94115, United States

Sylmar, California 91342, United States

Torrance, California 90502, United States

Port Elizabeth, Eastern Cape 6014, South Africa

Parana, Entre Rios 3100, Argentina

Paraná, Entre Ríos CP 3100, Argentina

Orlando, Florida 32801, United States

Orlando, Florida 32806, United States

Pensacola, Florida 32501, United States

West Palm Beach, Florida 33407, United States

Benoni, Gauteng 1501, South Africa

Pretoria, Gauteng 84, South Africa

Colonia El Ritiro, Guadalajara 44280, Mexico

Baroda, Gujarat 390001, India

Honolulu, Hawaii 96814, United States

Harbin, Heilongjiang 150086, China

Giessen, Hessen 35392, Germany

Kohtla Jarve, Ida Virumaa 30322, Estonia

Chicago, Illinois 60637, United States

Evanston, Illinois 60201, United States

North Chicago, Illinois 60064, United States

Springfield, Illinois 62701, United States

Springfield, Illinois 62791, United States

Guadalajara, Jalisco 44260, Mexico

Bangalore, Karnataka 560002, India

Wishaw, Lanarkshire ML2 0DP, United Kingdom

Pune, Maharashtra 411001, India

Winnipeg, Manitoba R3A 1R9, Canada

Baltimore, Maryland 21224, United States

Boston, Massachusetts 02215, United States

Tunuyan, Mendoza 5560, Argentina

Somers Point, New Jersey 08244, United States

Winston-Salem, North Carolina 27103, United States

Bochum, North Rhine-Westphalia 44789, Germany

Gelsenkirchen, North Rhine-Westphalia 45891, Germany

Rheine, North Rhine-Westphalia 48431, Germany

Muenster, Northrhien-Westphalia 48129, Germany

Lima, Ohio 45801, United States

Toledo, Ohio 43614, United States

Hamilton, Ontario L8V 1C3, Canada

Ottawa, Ontario K1H 8L6, Canada

West Reading, Pennsylvania 19610, United States

La Plata, Provincia de Buenos Aires 1900, Argentina

Mar del Plata, Provincia de Buenos Aires 7602, Argentina

San Miguel de Tucuman, Provincia de Tucuman 4000, Argentina

Chicoutimi, Quebec G7H 5H6, Canada

Montreal, Quebec H3T 1E2, Canada

Sherbrooke, Quebec J1H 5N4, Canada

Trois-Rivieres, Quebec G8Z 3R9, Canada

Jaipur, Rajasthan 302001, India

Rosario, Santa Fe 2000, Argentina

Hermosillo, Sonora 83190, Mexico

Columbia, South Carolina 29203, United States

Dallas, Texas 75203, United States

San Antonio, Texas 78229, United States

Melbourne, Victoria 3050, Australia

Melbourne, Victoria 3128, Australia

Birmingham, West Midlands B29 6JD, United Kingdom

Starting date: January 2007
Last updated: April 22, 2010