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.

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NCT00366249

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Study Location
Los Angeles, California, 90010, United States
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1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections, Diabetic Foot, Osteomyelitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Bacterial Infections, Diabetic Foot, OsteomyelitisStudy 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.
NCT00366249
  1. Los Angeles, California
  2. Los Angeles, California
  3. Northridge, California
  4. San Francisco, California
  5. Sylmar, California
  6. Torrance, California
  7. Orlando, Florida
  8. Orlando, Florida
  9. Pensacola, Florida
  10. West Palm Beach, Florida
  11. Honolulu, Hawaii
  12. Chicago, Illinois
  13. Evanston, Illinois
  14. North Chicago, Illinois
  15. Springfield, Illinois
  16. Springfield, Illinois
  17. Baltimore, Maryland
  18. Boston, Massachusetts
  19. Somers Point, New Jersey
  20. Winston-Salem, North Carolina
  21. Lima, Ohio
  22. Toledo, Ohio
  23. West Reading, Pennsylvania
  24. Columbia, South Carolina
  25. Dallas, Texas
  26. San Antonio, Texas
  27. Chivilcoy, Buenos Aires
  28. Ciudadela, 3 de Febrero, Buenos Aires
  29. Ciudadela, 3 de Febrero, Buenos Aires
  30. La Plata, Buenos Aires
  31. La Plata, Buenos Aires
  32. Loma Hermosa, Buenos Aires
  33. Loma Hermosa, Buenos Aires
  34. Merlo, Buenos Aires
  35. Moron, Buenos Aires
  36. Parana, Entre Rios
  37. Paraná, Entre Ríos
  38. Tunuyan, Mendoza
  39. La Plata, Provincia de Buenos Aires
  40. Mar del Plata, Provincia de Buenos Aires
  41. San Miguel de Tucuman, Provincia de Tucuman
  42. Rosario, Santa Fe
  43. Buenos Aires,
  44. Buenos Aires,
  45. Buenos Aires,
  46. Buenos Aires,
  47. Ciudad Autonoma de Buenos Aires,
  48. Cordoba,
  49. Cordoba,
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  54. Melbourne, Victoria
  55. Melbourne, Victoria
  56. Wien,
  57. Bornem,
  58. Brussel,
  59. Bruxelles,
  60. Bruxelles,
  61. Pellenberg,
  62. Rio de Janeiro,
  63. Sao Paulo,
  64. Vancouver, British Columbia
  65. Winnipeg, Manitoba
  66. Hamilton, Ontario
  67. Ottawa, Ontario
  68. Chicoutimi, Quebec
  69. Montreal, Quebec
  70. Sherbrooke, Quebec
  71. Trois-Rivieres, Quebec
  72. Santiago,
  73. Valdivia,
  74. Harbin, Heilongjiang
  75. Beijing,
  76. Beijing,
  77. Guangzhou,
  78. Tianjin,
  79. Bogota,
  80. Bogota,
  81. Zadar,
  82. Zagreb,
  83. Zagreb,
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  86. Tallinn,
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  90. Turku,
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  92. Tourcoing,
  93. Giessen, Hessen
  94. Bochum, North Rhine-Westphalia
  95. Gelsenkirchen, North Rhine-Westphalia
  96. Rheine, North Rhine-Westphalia
  97. Muenster, Northrhien-Westphalia
  98. Athens,
  99. Holargos, Athens,
  100. Rio-Patras,
  101. Budapest,
  102. Budapest,
  103. Budapest,
  104. Debrecen,
  105. Gyor,
  106. Kistarcsa,
  107. Szekesfehervar,
  108. Baroda, Gujarat
  109. Bangalore, Karnataka
  110. Pune, Maharashtra
  111. Jaipur, Rajasthan
  112. Abano terme (PD),
  113. Pisa,
  114. Rome,
  115. Gyeonggi-do,
  116. Seoul,
  117. Seoul,
  118. Seoul,
  119. Liepaja,
  120. Riga,
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  122. Riga,
  123. Riga,
  124. Riga,
  125. Kaunas,
  126. Kaunas,
  127. Kaunas,
  128. Klaipeda,
  129. Panevezys,
  130. Siauliai,
  131. Vilnius,
  132. Vilnius,
  133. Colonia El Ritiro, Guadalajara
  134. Guadalajara, Jalisco
  135. Hermosillo, Sonora
  136. Durango,
  137. Mendoza,
  138. San Luis Potosi,
  139. San Luis Potosi,
  140. Santa Fe,
  141. Veracruz,
  142. Panama,
  143. Lima,
  144. Lima,
  145. Bielsko-Biala,
  146. Cieszyn,
  147. Gdansk,
  148. Lodz,
  149. Warsaw,
  150. Wroclaw,
  151. Lisboa,
  152. Lisbon,
  153. Bacau,
  154. Bucharest,
  155. Cluj-Napoca,
  156. Lasi,
  157. Chelyabinsk,
  158. Ekaterinburg,
  159. Kemerovo,
  160. Moscow,
  161. Moscow,
  162. Moscow,
  163. Moscow,
  164. Moscow,
  165. Moscow,
  166. Nizhniy Novgorod,
  167. Nizhny Novgorod,
  168. Novosibirsk,
  169. Omsk,
  170. Smolensk,
  171. St. Petersburg,
  172. St. Petersburg,
  173. Yaroslavl,
  174. Banska Bystrica,
  175. Banska.Bysterica,
  176. Bratislava,
  177. Lubochna,
  178. Martin,
  179. Nitra,
  180. Nove Zamky,
  181. Port Elizabeth, Eastern Cape
  182. Benoni, Gauteng
  183. Pretoria, Gauteng
  184. Barcelona,
  185. Getafe Madrid,
  186. Granada,
  187. Madrid,
  188. Palma de Mallorca,
  189. Copenhagen,
  190. Huddinge,
  191. Uppsala,
  192. Basel,
  193. Geneva,
  194. Tainan,
  195. Taoyuan Hsien,
  196. Adana,
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  200. Dnepropetrovsk,
  201. Kiev,
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  203. Kyiv,
  204. Lviv,
  205. Vinnytsia,
  206. Zaporozhye,
  207. Wishaw, Lanarkshire
  208. Birmingham, West Midlands
  209. Birmingham,
  210. London,
  211. Oxford,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Infections
  • Diabetic Foot
  • Osteomyelitis
Intervention  ICMJE
  • Drug: Tigecycline
    150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
  • Drug: 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).
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Tigecycline
  • Active Comparator: B
    Intervention: Drug: Ertapenem
Publications * Lauf L, Ozsvár Z, Mitha I, Regöly-Mérei 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2009)		1061
Original Enrollment  ICMJE
 (submitted: August 17, 2006)		781
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Croatia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Panama,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366249
Other Study ID Numbers  ICMJE 3074K5-319
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Hungary, [email protected]
Principal Investigator:Trial ManagerFor Spain, [email protected]
Principal Investigator:Trial ManagerFor Taiwan, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Canada, [email protected]
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor Croatia, [email protected]
Principal Investigator:Trial ManagerFor Latvia, [email protected]
Principal Investigator:Trial ManagerFor Lithuania, [email protected]
Principal Investigator:Trial ManagerFor Romania, [email protected]
Principal Investigator:Trial ManagerFor Argentina, [email protected]
Principal Investigator:Trial ManagerFor Brazil, [email protected]
Principal Investigator:Trial ManagerFor Chile, [email protected]
Principal Investigator:Trial ManagerFor Mexico, [email protected]
Principal Investigator:Trial ManagerFor Sweden, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Denmark, [email protected]
Principal Investigator:Trial ManagerFor Estonia, [email protected]
Principal Investigator:Trial ManagerFor Finland, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor UK/Great Britian: [email protected]
Principal Investigator:Trial ManagerFor Switzerland, [email protected]
Principal Investigator:Trial ManagerFor Greece, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Russia, [email protected]
Principal Investigator:Trial ManagerFor Slovakia, [email protected]
Principal Investigator:Trial ManagerFor Turkey, [email protected]
Principal Investigator:Trial ManagerFor Ukraine, [email protected]
Principal Investigator:Trial ManagerFor China, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP