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.
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, 1180
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Buenos Aires, Argentina, 1428
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Buenos Aires, Argentina, CP 1428
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Buenos Aires, Argentina, CP C1180 AAX
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Ciudad Autonoma de Buenos Aires, Argentina, 1181
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Cordoba, Argentina, 5000
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Cordoba, Argentina, 5004
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Cordoba, Argentina, 5016
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Cordoba, Argentina, CP 5000
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Cordoba, Argentina, CP 5016
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Mendoza, Argentina, 5500
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Buenos Aires
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Chivilcoy, Buenos Aires, Argentina, 6620
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Ciudadela, 3 de Febrero, Buenos Aires, Argentina, 1702
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Ciudadela, 3 de Febrero, Buenos Aires, Argentina, CP 1702
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La Plata, Buenos Aires, Argentina, 1072
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La Plata, Buenos Aires, Argentina, CP 1900
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Loma Hermosa, Buenos Aires, Argentina, 1657
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Loma Hermosa, Buenos Aires, Argentina, CP 1657
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Merlo, Buenos Aires, Argentina, 1722
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Moron, Buenos Aires, Argentina, 1072
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Entre Rios
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Parana, Entre Rios, Argentina, 3100
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Entre Ríos
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Paraná, Entre Ríos, Argentina, CP 3100
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Mendoza
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Tunuyan, Mendoza, Argentina, 5560
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Provincia de Buenos Aires
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La Plata, Provincia de Buenos Aires, Argentina, 1900
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Mar del Plata, Provincia de Buenos Aires, Argentina, 7602
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Provincia de Tucuman
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San Miguel de Tucuman, Provincia de Tucuman, Argentina, 4000
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
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Victoria
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Melbourne, Victoria, Australia, 3050
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Melbourne, Victoria, Australia, 3128
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Wien, Austria, 1100
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Bornem, Belgium, 2880
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1070
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Bruxelles, Belgium, 1080
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Pellenberg, Belgium, 3212
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Rio de Janeiro, Brazil, 20211-340
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Sao Paulo, Brazil, 05422-970
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
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Ontario
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Hamilton, Ontario, Canada, L8V 1C3
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Ottawa, Ontario, Canada, K1H 8L6
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Montreal, Quebec, Canada, H3T 1E2
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Sherbrooke, Quebec, Canada, J1H 5N4
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Trois-Rivieres, Quebec, Canada, G8Z 3R9
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Santiago, Chile
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Valdivia, Chile
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Beijing, China, 100730
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Beijing, China, 100101
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Guangzhou, China, 510120
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Tianjin, China, 300070
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Heilongjiang
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Harbin, Heilongjiang, China, 150086
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Bogota, Colombia
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Bogota, Colombia, NAP
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Zadar, Croatia, 23 000
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Zagreb, Croatia, 10000
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Zagreb, Croatia, 10 000
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Odense, Denmark, 5000
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Tallinn, Estonia, 13419
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Tartu, Estonia, 51014
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Tartu, Estonia, 50410
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Ida Virumaa
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Kohtla Jarve, Ida Virumaa, Estonia, 30322
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Kuopio, Finland, 70210
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Turku, Finland, 20520
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Strasbourg, France, 67000
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Tourcoing, France, 59200
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Hessen
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Giessen, Hessen, Germany, 35392
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North Rhine-Westphalia
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Bochum, North Rhine-Westphalia, Germany, 44789
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Gelsenkirchen, North Rhine-Westphalia, Germany, 45891
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Rheine, North Rhine-Westphalia, Germany, 48431
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Northrhien-Westphalia
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Muenster, Northrhien-Westphalia, Germany, 48129
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Athens, Greece, 106 76
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Holargos, Athens, Greece, 11527
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Rio-Patras, Greece, 265 04
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Budapest, Hungary, 1082
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Budapest, Hungary, 1076
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Budapest, Hungary, H-1027
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Debrecen, Hungary, 4012
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Gyor, Hungary, 9024
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Kistarcsa, Hungary, 2143
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Szekesfehervar, Hungary, 8000
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Gujarat
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Baroda, Gujarat, India, 390001
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Karnataka
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Bangalore, Karnataka, India, 560002
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Maharashtra
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Pune, Maharashtra, India, 411001
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Rajasthan
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Jaipur, Rajasthan, India, 302001
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Abano terme (PD), Italy, 35031
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Pisa, Italy, 56124
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Rome, Italy, 133
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Gyeonggi-do, Korea, Republic of, 425-801
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 136-075
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Liepaja, Latvia, 3401
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Riga, Latvia, 1002
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Riga, Latvia, 1038
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Riga, Latvia, LV-1038
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Riga, Latvia, LV-1001
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Riga, Latvia, 1001
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Kaunas, Lithuania, 47144
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Kaunas, Lithuania, 50009
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Kaunas, Lithuania, LT-50009
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Klaipeda, Lithuania, 92288
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Panevezys, Lithuania, 35144
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Siauliai, Lithuania, 76231
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Vilnius, Lithuania, 10207
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Vilnius, Lithuania, LT-10207
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Durango, Mexico, 34000
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Mendoza, Mexico, CP 5500
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San Luis Potosi, Mexico, 78210
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San Luis Potosi, Mexico, CP 78210
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Santa Fe, Mexico, CP 2000
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Veracruz, Mexico, 91910
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Guadalajara
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Colonia El Ritiro, Guadalajara, Mexico, 44280
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Jalisco
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Guadalajara, Jalisco, Mexico, 44260
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Sonora
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Hermosillo, Sonora, Mexico, 83190
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Panama, Panama, 907
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Lima, Peru, Lima 11
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Lima, Peru, Lima 31
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Bielsko-Biala, Poland, 43-300
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Cieszyn, Poland, 43-400
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Gdansk, Poland, 80-211
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Lodz, Poland, 91-425
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Warsaw, Poland, 02-097
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Wroclaw, Poland, 50-326
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Lisboa, Portugal, 1169-050
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Lisbon, Portugal, 1495-005
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Bacau, Romania, 600114
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Bucharest, Romania, 20475
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Cluj-Napoca, Romania, 400006
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Lasi, Romania, 700111
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Chelyabinsk, Russian Federation, 454 021
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Ekaterinburg, Russian Federation, 620109
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Kemerovo, Russian Federation, 650061
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Moscow, Russian Federation, 111020
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Moscow, Russian Federation, 129110
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Moscow, Russian Federation, 127299
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Moscow, Russian Federation, 127486
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Moscow, Russian Federation, 129327
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Moscow, Russian Federation, 113152
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Nizhniy Novgorod, Russian Federation, 603005
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Nizhny Novgorod, Russian Federation, 603076
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Novosibirsk, Russian Federation, 630117
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Omsk, Russian Federation, 644021
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Smolensk, Russian Federation, 214019
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St. Petersburg, Russian Federation, 196247
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St. Petersburg, Russian Federation, 198095
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Yaroslavl, Russian Federation
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Banska Bystrica, Slovakia, 975 17
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Banska.Bysterica, Slovakia, 97517
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Bratislava, Slovakia, 813 69
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Lubochna, Slovakia, 034 91
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Martin, Slovakia, 036 59
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Nitra, Slovakia, 949 01
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Nove Zamky, Slovakia, 9401
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Eastern Cape
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Port Elizabeth, Eastern Cape, South Africa, 6014
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Gauteng
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Benoni, Gauteng, South Africa, 1501
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Pretoria, Gauteng, South Africa, 84
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Barcelona, Spain, 8907
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Getafe Madrid, Spain, 28905
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Granada, Spain, 18012
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Madrid, Spain, 28007
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Palma de Mallorca, Spain, 7198
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Copenhagen, Sweden, 2400
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Huddinge, Sweden, 141 86
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Uppsala, Sweden, 751 85
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Basel, Switzerland, CH 4031
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Geneva, Switzerland, CH 1211
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Tainan, Taiwan
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Taoyuan Hsien, Taiwan
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Adana, Turkey, 1330
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Capa-Istanbul, Turkey, 34390
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Istanbul, Turkey, 34303
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Cherkassy, Ukraine, 18009
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Dnepropetrovsk, Ukraine, 49001
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Kiev, Ukraine, 2125
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Kyiv, Ukraine, 02175
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Kyiv, Ukraine, 2175
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Lviv, Ukraine, 79010
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Vinnytsia, Ukraine, 21010
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Zaporozhye, Ukraine, 69600
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Birmingham, United Kingdom, B95SS
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London, United Kingdom, SE5 9RS
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Oxford, United Kingdom, OX3 7LD
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Lanarkshire
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Wishaw, Lanarkshire, United Kingdom, ML2 0DP
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West Midlands
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Birmingham, West Midlands, United Kingdom, B29 6JD
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California
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Los Angeles, California, United States, 90010
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Los Angeles, California, United States, 91342
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Northridge, California, United States, 91326
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San Francisco, California, United States, 94115
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Sylmar, California, United States, 91342
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Torrance, California, United States, 90502
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Florida
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Orlando, Florida, United States, 32806
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Orlando, Florida, United States, 32801
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Pensacola, Florida, United States, 32501
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West Palm Beach, Florida, United States, 33407
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Hawaii
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Honolulu, Hawaii, United States, 96814
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Illinois
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Chicago, Illinois, United States, 60637
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Evanston, Illinois, United States, 60201
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North Chicago, Illinois, United States, 60064
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Springfield, Illinois, United States, 62701
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Springfield, Illinois, United States, 62791
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Maryland
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Baltimore, Maryland, United States, 21224
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Massachusetts
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Boston, Massachusetts, United States, 02215
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New Jersey
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Somers Point, New Jersey, United States, 08244
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Lima, Ohio, United States, 45801
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Toledo, Ohio, United States, 43614
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Pennsylvania
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West Reading, Pennsylvania, United States, 19610
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South Carolina
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Columbia, South Carolina, United States, 29203
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Texas
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Dallas, Texas, United States, 75203
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San Antonio, Texas, United States, 78229
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Active Comparator: A
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150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
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Active Comparator: B
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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).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients With Clinical Response of Cure Vs. Failure.
Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose
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Cure: Recovery so no added antibiotic therapy.
Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.
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Test of cure visit (TOC): Assessed at least 12 days post last dose
|
|
Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.
Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose
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Cure: Recovery so no added antibiotic therapy.
Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.
Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
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Test of cure visit (TOC): Assessed at least 12 days post last dose
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.
Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
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Cure: Recovery so no added antibiotic therapy.
Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.
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Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
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Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.
Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
|
Cure: Recovery so no added antibiotic therapy.
Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.
Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
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Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
|
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Number of Patients With Microbiologic Response of Eradication.
Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose
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Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.
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Test of cure visit (TOC): Assessed at least 12 days post last dose
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Trial Manager, For Australia, medinfo@wyeth.com
- Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
- Principal Investigator: Trial Manager, For Greece, decresg@wyeth.com
- Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
- Principal Investigator: Trial Manager, For Romania, WVPIMED@wyeth.com
- Principal Investigator: Trial Manager, For Spain, infomed@wyeth.com
- Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
- Principal Investigator: Trial Manager, For Switzerland, med@wyeth.com
- Principal Investigator: Trial Manager, For Turkey, Erisc@wyeth.com
- Principal Investigator: Trial Manager, For Brazil, xavierl@wyeth.com
- Principal Investigator: Trial manager, For Hungary, WPBUMED@wyeth.com
- Principal Investigator: Trial Manager, For Mexico, gomezzlj@wyeth.com
- Principal Investigator: Trial Manager, For Canada, clintrialparticipation@wyeth.com
- Principal Investigator: Trial Manager, For Croatia, WPBUMED@wyeth.com
- Principal Investigator: Trial Manager, For Latvia, WPVIMED@wyeth.com
- Principal Investigator: Trial Manager, For Lithuania, WPVIMED@wyeth.com
- Principal Investigator: Trial Manager, For Argentina, Scheima@wyeth.com
- Principal Investigator: Trial Manager, For Chile, scheima@wyeth.com
- Principal Investigator: Trial Manager, For Sweden, MedInfoNord@wyeth.com
- Principal Investigator: Trial Manager, For Denmark, medinfonord@wyeth.com
- Principal Investigator: Trial Manager, For Estonia, WVPMED@wyeth.com
- Principal Investigator: Trial Manager, For Finland, MedInfoNord@wyeth.com
- Principal Investigator: Trial Manager, For UK/Great Britian: ukmedinfo@wyeth.com
- Principal Investigator: Trial Manager, For Russia, WVPIMED@wyeth.com
- Principal Investigator: Trial Manager, For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com
- Principal Investigator: Trial Manager, For Ukraine, WVPIMED@wyeth.com
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Musculoskeletal Diseases
- Bacterial Infections and Mycoses
- Bone Diseases
- Bone Diseases, Infectious
- Foot Ulcer
- Diabetic Foot
- Infections
- Communicable Diseases
- Bacterial Infections
- Osteomyelitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Tigecycline
- Ertapenem
Other Study ID Numbers
Other Study ID Numbers
- 3074K5-319
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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