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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.

Last updated on December 2, 2019

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Study Location
Los Angeles, California, 90010 United States
Contact
1-800-718-1021
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
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- People with additional significant disease, infection with resistant pathogens,
contraindication, or hypersensitivity to any test article or related antibiotic.

NCT00366249
Pfizer
Completed
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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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 SummaryThe 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 DescriptionNot 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 DateMarch 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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateApril 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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