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.

April 22, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1061

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1180
      • Buenos Aires, Argentina, 1428
      • Buenos Aires, Argentina, CP 1428
      • Buenos Aires, Argentina, CP C1180 AAX
      • Ciudad Autonoma de Buenos Aires, Argentina, 1181
      • Cordoba, Argentina, 5000
      • Cordoba, Argentina, 5004
      • Cordoba, Argentina, 5016
      • Cordoba, Argentina, CP 5000
      • Cordoba, Argentina, CP 5016
      • Mendoza, Argentina, 5500
    • Buenos Aires
      • Chivilcoy, Buenos Aires, Argentina, 6620
      • Ciudadela, 3 de Febrero, Buenos Aires, Argentina, 1702
      • Ciudadela, 3 de Febrero, Buenos Aires, Argentina, CP 1702
      • La Plata, Buenos Aires, Argentina, 1072
      • La Plata, Buenos Aires, Argentina, CP 1900
      • Loma Hermosa, Buenos Aires, Argentina, 1657
      • Loma Hermosa, Buenos Aires, Argentina, CP 1657
      • Merlo, Buenos Aires, Argentina, 1722
      • Moron, Buenos Aires, Argentina, 1072
    • Entre Rios
      • Parana, Entre Rios, Argentina, 3100
    • Entre Ríos
      • Paraná, Entre Ríos, Argentina, CP 3100
    • Mendoza
      • Tunuyan, Mendoza, Argentina, 5560
    • Provincia de Buenos Aires
      • La Plata, Provincia de Buenos Aires, Argentina, 1900
      • Mar del Plata, Provincia de Buenos Aires, Argentina, 7602
    • Provincia de Tucuman
      • San Miguel de Tucuman, Provincia de Tucuman, Argentina, 4000
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3050
      • Melbourne, Victoria, Australia, 3128
  • Austria
      • Wien, Austria, 1100
  • Belgium
      • Bornem, Belgium, 2880
      • Brussel, Belgium, 1090
      • Bruxelles, Belgium, 1070
      • Bruxelles, Belgium, 1080
      • Pellenberg, Belgium, 3212
  • Brazil
      • Rio de Janeiro, Brazil, 20211-340
      • Sao Paulo, Brazil, 05422-970
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
      • Ottawa, Ontario, Canada, K1H 8L6
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Montreal, Quebec, Canada, H3T 1E2
      • Sherbrooke, Quebec, Canada, J1H 5N4
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
  • Chile
      • Santiago, Chile
      • Valdivia, Chile
  • China
      • Beijing, China, 100730
      • Beijing, China, 100101
      • Guangzhou, China, 510120
      • Tianjin, China, 300070
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
  • Colombia
      • Bogota, Colombia
      • Bogota, Colombia, NAP
  • Croatia
      • Zadar, Croatia, 23 000
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 10 000
  • Denmark
      • Odense, Denmark, 5000
  • Estonia
      • Tallinn, Estonia, 13419
      • Tartu, Estonia, 51014
      • Tartu, Estonia, 50410
    • Ida Virumaa
      • Kohtla Jarve, Ida Virumaa, Estonia, 30322
  • Finland
      • Kuopio, Finland, 70210
      • Turku, Finland, 20520
  • France
      • Strasbourg, France, 67000
      • Tourcoing, France, 59200
  • Germany
    • Hessen
      • Giessen, Hessen, Germany, 35392
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44789
      • Gelsenkirchen, North Rhine-Westphalia, Germany, 45891
      • Rheine, North Rhine-Westphalia, Germany, 48431
    • Northrhien-Westphalia
      • Muenster, Northrhien-Westphalia, Germany, 48129
  • Greece
      • Athens, Greece, 106 76
      • Holargos, Athens, Greece, 11527
      • Rio-Patras, Greece, 265 04
  • Hungary
      • Budapest, Hungary, 1082
      • Budapest, Hungary, 1076
      • Budapest, Hungary, H-1027
      • Debrecen, Hungary, 4012
      • Gyor, Hungary, 9024
      • Kistarcsa, Hungary, 2143
      • Szekesfehervar, Hungary, 8000
  • India
    • Gujarat
      • Baroda, Gujarat, India, 390001
    • Karnataka
      • Bangalore, Karnataka, India, 560002
    • Maharashtra
      • Pune, Maharashtra, India, 411001
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
  • Italy
      • Abano terme (PD), Italy, 35031
      • Pisa, Italy, 56124
      • Rome, Italy, 133
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 425-801
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 135-710
      • Seoul, Korea, Republic of, 136-075
  • Latvia
      • Liepaja, Latvia, 3401
      • Riga, Latvia, 1002
      • Riga, Latvia, 1038
      • Riga, Latvia, LV-1038
      • Riga, Latvia, LV-1001
      • Riga, Latvia, 1001
  • Lithuania
      • Kaunas, Lithuania, 47144
      • Kaunas, Lithuania, 50009
      • Kaunas, Lithuania, LT-50009
      • Klaipeda, Lithuania, 92288
      • Panevezys, Lithuania, 35144
      • Siauliai, Lithuania, 76231
      • Vilnius, Lithuania, 10207
      • Vilnius, Lithuania, LT-10207
  • Mexico
      • Durango, Mexico, 34000
      • Mendoza, Mexico, CP 5500
      • San Luis Potosi, Mexico, 78210
      • San Luis Potosi, Mexico, CP 78210
      • Santa Fe, Mexico, CP 2000
      • Veracruz, Mexico, 91910
    • Guadalajara
      • Colonia El Ritiro, Guadalajara, Mexico, 44280
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44260
    • Sonora
      • Hermosillo, Sonora, Mexico, 83190
  • Panama
      • Panama, Panama, 907
  • Peru
      • Lima, Peru, Lima 11
      • Lima, Peru, Lima 31
  • Poland
      • Bielsko-Biala, Poland, 43-300
      • Cieszyn, Poland, 43-400
      • Gdansk, Poland, 80-211
      • Lodz, Poland, 91-425
      • Warsaw, Poland, 02-097
      • Wroclaw, Poland, 50-326
  • Portugal
      • Lisboa, Portugal, 1169-050
      • Lisbon, Portugal, 1495-005
  • Romania
      • Bacau, Romania, 600114
      • Bucharest, Romania, 20475
      • Cluj-Napoca, Romania, 400006
      • Lasi, Romania, 700111
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454 021
      • Ekaterinburg, Russian Federation, 620109
      • Kemerovo, Russian Federation, 650061
      • Moscow, Russian Federation, 111020
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 127299
      • Moscow, Russian Federation, 127486
      • Moscow, Russian Federation, 129327
      • Moscow, Russian Federation, 113152
      • Nizhniy Novgorod, Russian Federation, 603005
      • Nizhny Novgorod, Russian Federation, 603076
      • Novosibirsk, Russian Federation, 630117
      • Omsk, Russian Federation, 644021
      • Smolensk, Russian Federation, 214019
      • St. Petersburg, Russian Federation, 196247
      • St. Petersburg, Russian Federation, 198095
      • Yaroslavl, Russian Federation
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
      • Banska.Bysterica, Slovakia, 97517
      • Bratislava, Slovakia, 813 69
      • Lubochna, Slovakia, 034 91
      • Martin, Slovakia, 036 59
      • Nitra, Slovakia, 949 01
      • Nove Zamky, Slovakia, 9401
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6014
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
      • Pretoria, Gauteng, South Africa, 84
  • Spain
      • Barcelona, Spain, 8907
      • Getafe Madrid, Spain, 28905
      • Granada, Spain, 18012
      • Madrid, Spain, 28007
      • Palma de Mallorca, Spain, 7198
  • Sweden
      • Copenhagen, Sweden, 2400
      • Huddinge, Sweden, 141 86
      • Uppsala, Sweden, 751 85
  • Switzerland
      • Basel, Switzerland, CH 4031
      • Geneva, Switzerland, CH 1211
  • Taiwan
      • Tainan, Taiwan
      • Taoyuan Hsien, Taiwan
  • Turkey
      • Adana, Turkey, 1330
      • Capa-Istanbul, Turkey, 34390
      • Istanbul, Turkey, 34303
  • Ukraine
      • Cherkassy, Ukraine, 18009
      • Dnepropetrovsk, Ukraine, 49001
      • Kiev, Ukraine, 2125
      • Kyiv, Ukraine, 02175
      • Kyiv, Ukraine, 2175
      • Lviv, Ukraine, 79010
      • Vinnytsia, Ukraine, 21010
      • Zaporozhye, Ukraine, 69600
  • United Kingdom
      • Birmingham, United Kingdom, B95SS
      • London, United Kingdom, SE5 9RS
      • Oxford, United Kingdom, OX3 7LD
    • Lanarkshire
      • Wishaw, Lanarkshire, United Kingdom, ML2 0DP
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B29 6JD
  • United States
    • California
      • Los Angeles, California, United States, 90010
      • Los Angeles, California, United States, 91342
      • Northridge, California, United States, 91326
      • San Francisco, California, United States, 94115
      • Sylmar, California, United States, 91342
      • Torrance, California, United States, 90502
    • Florida
      • Orlando, Florida, United States, 32806
      • Orlando, Florida, United States, 32801
      • Pensacola, Florida, United States, 32501
      • West Palm Beach, Florida, United States, 33407
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Evanston, Illinois, United States, 60201
      • North Chicago, Illinois, United States, 60064
      • Springfield, Illinois, United States, 62701
      • Springfield, Illinois, United States, 62791
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Lima, Ohio, United States, 45801
      • Toledo, Ohio, United States, 43614
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19610
    • South Carolina
      • Columbia, South Carolina, United States, 29203
    • Texas
      • Dallas, Texas, United States, 75203
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Tigecycline
150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
Active Comparator: B
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).

What is the study measuring?

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
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.
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
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.
Test of cure visit (TOC): Assessed at least 12 days post last dose

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
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.
Test of cure visit (TOC): 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.
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.
Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
Number of Patients With Microbiologic Response of Eradication.
Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose
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.
Test of cure visit (TOC): Assessed at least 12 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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