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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 May 11, 2018

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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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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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Bacterial Infections
  • Diabetic Foot
  • Osteomyelitis
  • 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).
  • Active Comparator: A
    Intervention: Drug: Tigecycline
  • Active Comparator: B
    Intervention: Drug: Ertapenem
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.
 
Completed
1061
March 2009
March 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00366249
3074K5-319
Yes
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For Hungary, [email protected]
Principal Investigator: Trial Manager For Spain, [email protected]
Principal Investigator: Trial Manager For Taiwan, [email protected]
Principal Investigator: Trial Manager For South Africa, [email protected]
Principal Investigator: Trial Manager For Canada, [email protected]
Principal Investigator: Trial Manager For Australia, [email protected]
Principal Investigator: Trial Manager For Austria, [email protected]
Principal Investigator: Trial Manager For Croatia, [email protected]
Principal Investigator: Trial Manager For Latvia, [email protected]
Principal Investigator: Trial Manager For Lithuania, [email protected]
Principal Investigator: Trial Manager For Romania, [email protected]
Principal Investigator: Trial Manager For Argentina, [email protected]
Principal Investigator: Trial Manager For Brazil, [email protected]
Principal Investigator: Trial Manager For Chile, [email protected]
Principal Investigator: Trial Manager For Mexico, [email protected]
Principal Investigator: Trial Manager For Sweden, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Denmark, [email protected]
Principal Investigator: Trial Manager For Estonia, [email protected]
Principal Investigator: Trial Manager For Finland, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Principal Investigator: Trial Manager For UK/Great Britian: [email protected]
Principal Investigator: Trial Manager For Switzerland, [email protected]
Principal Investigator: Trial Manager For Greece, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For Russia, [email protected]
Principal Investigator: Trial Manager For Slovakia, [email protected]
Principal Investigator: Trial Manager For Turkey, [email protected]
Principal Investigator: Trial Manager For Ukraine, [email protected]
Principal Investigator: Trial Manager For China, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the

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

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