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Study Evaluating the Safety and Efficacy of a Once-Daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections
This study is currently recruiting participants.
Verified by Wyeth, April 2008
First Received: August 17, 2006   Last Updated: April 25, 2008   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00366249
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Diabetic Foot
Osteomyelitis
Drug: Tigecycline
Drug: Ertapenem
Phase III

MedlinePlus related topics: Bacterial Infections Diabetes Diabetes Complications Diabetic Foot Foot Health
Drug Information available for: L 749345 Ertapenem Tigecycline
U.S. FDA Resources
Study Type: Interventional
Study Design: Active Control, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
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

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • 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. [ Time Frame: 14 to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 781
Study Start Date: September 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Drug: Tigecycline
150 mg Tygecicline once-daily IV infusion every 24 hours during 28 days or 42 days for the substudy wth osteomyelitis
B: Active Comparator Drug: Ertapenem
1 gr of Ertapenem IV infusion every 24 hours, After at the Investigator discretion IV Vancomycin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366249

Contacts
Contact: Trial Manager clintrialparticipation@wyeth.com

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Locations
United States, California
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Northridge, California, United States, 91326
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San Francisco, California, United States, 94115
Recruiting
Sylmar, California, United States, 91342
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Los Angeles, California, United States, 91342
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Los Angeles, California, United States, 90010
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Torrance, California, United States, 90502
United States, Florida
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Orlando, Florida, United States, 32806
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Orlando, Florida, United States, 32801
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West Palm Beach, Florida, United States, 33407
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Pensacola, Florida, United States, 32501
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Honolulu, Hawaii, United States, 96814
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Springfield, Illinois, United States, 62791
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Springfield, Illinois, United States, 62701
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Evanston, Illinois, United States, 60201
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Chicago, Illinois, United States, 60637
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Boston, Massachusetts, United States, 02215
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Mendoza, Argentina, 5500
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Cordoba, Argentina, 5016
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San Miguel de Tucuman, Provincia de Tucuman, Argentina, 4000
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Rosario, Santa Fe, Argentina, 2000
Australia, Victoria
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Melbourne, Victoria, Australia, 3128
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Austria
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Wien, Austria, 1100
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Graz, Austria, 8036
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Brussel, Belgium, 1090
Brazil
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Porto Alegre, Brazil, 90020-090
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Fortaleza, Brazil, 60414-021
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Sorocaba, Brazil, 18030-210
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Goiania, Brazil, 74043-011
Withdrawn
Sao Jose do Rio Preto, Brazil, 15090-000
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China
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Harbin, Heilongjiang, China, 150086
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Denmark
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Estonia
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Estonia, Ida Virumaa
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Kohtla Jarve, Ida Virumaa, Estonia, 30322
Finland
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Turku, Finland, 20520
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Kuopio, Finland, 70210
France
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Nimes, France, 30900
Terminated
Tourcoing, France, 59200
Terminated
Strasbourg, France, 67000
Germany
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Frankfurt, Germany, 60318
Germany, Hessen
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Germany, North Rhine-Westphalia
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Rheine, North Rhine-Westphalia, Germany, 48431
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Muenster, Northrhien-Westphalia, Germany, 48129
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Rio-Patras, Greece, 265 04
Hungary
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Debrecen, Hungary, 4012
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Gyor, Hungary, 9024
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Pune, Maharashtra, India, 411001
India, Rajasthan
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Jaipur, Rajasthan, India, 302001
Italy
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Ancona, Italy, 60100
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Pisa, Italy, 56124
Korea, Republic of
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 136-075
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Gyeonggi-do, Korea, Republic of, 425-801
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Seoul, Korea, Republic of, 135-710
Latvia
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Riga, Latvia, 1001
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Riga, Latvia, 1002
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Riga, Latvia, LV-1001
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Riga, Latvia, LV-1038
Lithuania
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Kaunas, Lithuania, 47144
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Siauliai, Lithuania, 76231
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Klaipeda, Lithuania, 92288
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Vilnius, Lithuania, 10207
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Panevezys, Lithuania, 35144
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Kaunas, Lithuania, 50009
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Vilnius, Lithuania, LT-10207
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Klaipeda, Lithuania, 92288
Mexico
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Durango, Mexico, 34000
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Mexico, Guadalajara
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Colonia El Ritiro, Guadalajara, Mexico, 44280
Mexico, Jalisco
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Mexico, Sonora
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Hermosillo, Sonora, Mexico, 83190
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Panama, Panama, 907
Peru
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Lima, Peru, Lima 11
Poland
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Gdansk, Poland, 80-211
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Wroclaw, Poland, 50-326
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Bielsko-Biala, Poland, 43-300
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Lodz, Poland, 91-425
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Warsaw, Poland, 02-097
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Cieszyn, Poland, 43-400
Portugal
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Lisboa, Portugal, 1169-050
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Lisbon, Portugal, 1495-005
Romania
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Bucharest, Romania, 20475
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Cluj-Napoca, Romania, 400006
Recruiting
Lasi, Romania, 700111
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Bacau, Romania, 600114
Russian Federation
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Smolensk, Russian Federation, 214019
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St. Petersburg, Russian Federation, 198095
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Moscow, Russian Federation, 129327
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Kemerovo, Russian Federation, 650061
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Yaroslavl, Russian Federation
Recruiting
Moscow, Russian Federation, 129110
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Moscow, Russian Federation, 113152
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Moscow, Russian Federation, 111020
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Moscow, Russian Federation, 127299
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Chelyabinsk, Russian Federation, 454 021
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Nizhny Novgorod, Russian Federation, 603076
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Omsk, Russian Federation, 644021
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Moscow, Russian Federation, 127486
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Ekaterinburg, Russian Federation, 620109
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Novosibirsk, Russian Federation, 630117
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St. Petersburg, Russian Federation, 196247
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Nizhniy Novgorod, Russian Federation, 603005
Slovakia
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Bratislava, Slovakia, 813 69
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Nitra, Slovakia, 949 01
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Nove Zamky, Slovakia, 9401
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Martin, Slovakia, 036 59
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Lubochna, Slovakia, 034 91
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Banska Bystrica, Slovakia, 975 17
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Banska.Bysterica, Slovakia, 97517
South Africa, Eastern Cape
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South Africa, Gauteng
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Pretoria, Gauteng, South Africa, 84
Spain
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Granada, Spain, 18012
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Getafe Madrid, Spain, 28905
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Madrid, Spain, 28007
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Palma de Mallorca, Spain, 7198
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Barcelona, Spain, 8907
Sweden
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Malmo, Sweden, 205 02
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Huddinge, Sweden, 141 86
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Copenhagen, Sweden, 2400
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Uppsala, Sweden, 751 85
Switzerland
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Vinnytsia, Ukraine, 21010
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Lviv, Ukraine, 79010
Terminated
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Kiev, Ukraine, 2125
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Zaporozhye, Ukraine, 69600
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Kyiv, Ukraine, 02175
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United Kingdom, West Midlands
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Birmingham, West Midlands, United Kingdom, B29 6JD
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Hungary, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com
Principal Investigator: Trial Manager For South Africa, ZAFinfo@wyeth.com
Principal Investigator: Trial Manager For Canada, clintrialparticipation@wyeth.com
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
Principal Investigator: Trial Manager For Austria, WPVIMED@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 Romania, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Argentina, Scheima@wyeth.com
Principal Investigator: Trial Manager For Brazil, xavierl@wyeth.com
Principal Investigator: Trial Manager For Chile, scheima@wyeth.com
Principal Investigator: Trial Manager For China, medinfo@wyeth.com
Principal Investigator: Trial Manager For Sweden, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For Germany, medinfoDEU@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 France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For UK/Great Britian: ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For Switzerland, med@wyeth.com
Principal Investigator: Trial Manager For Greece, decresg@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@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 Turkey, Erisc@wyeth.com
Principal Investigator: Trial Manager For Ukraine, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezzlj@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 3074K5-319
Study First Received: August 17, 2006
Last Updated: April 25, 2008
ClinicalTrials.gov Identifier: NCT00366249     History of Changes
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Australia: Human Research Ethics Committee;   Brazil: Ministry of Health;   Canada: Health Canada;   Chile: Instituto de Salud Publica de Chile;   China: Ministry of Health;   European Union: European Medicines Agency;   Hong Kong: Department of Health;   India: Ministry of Health;   Korea: Food and Drug Administration;   Mexico: Ethics Committee;   Peru: General Directorate of Pharmaceuticals, Devices, and Drugs;   Singapore: Health Sciences Authority;   South Africa: Medicines Control Council;   Taiwan: Department of Health;   United States: Food and Drug Administration

Keywords provided by Wyeth:
Diabetes Complications
Diabetic foot infection
Foot ulcer
Osteomyelitis
Skin infection

Study placed in the following topic categories:
Bacterial Infections
Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Tigecycline
Ulcer
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Bone Diseases
Diabetic Angiopathies
Ertapenem
Anti-Bacterial Agents
Skin Diseases, Infectious
Musculoskeletal Diseases
Vancomycin
Endocrinopathy
Skin Ulcer
Diabetes Complications
Osteomyelitis
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Diabetic Neuropathies
Foot Ulcer
Diabetic Foot
Diabetic Angiopathies
Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Tigecycline
Infection
Bone Diseases
Anti-Bacterial Agents
Musculoskeletal Diseases
Therapeutic Uses
Cardiovascular Diseases
Diabetes Complications
Skin Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Pharmacologic Actions
Bone Diseases, Infectious
Ertapenem
Skin Ulcer
Leg Ulcer
Osteomyelitis

ClinicalTrials.gov processed this record on March 16, 2009