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.

• 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 ] [ Designated as safety issue: No ]
  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.
• 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 ] [ Designated as safety issue: No ]
  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.

• 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 ] [ Designated as safety issue: No ]
  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.
• 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 ] [ Designated as safety issue: No ]
  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.
• Number of Patients With Microbiologic Response of Eradication. [ Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose ] [ Designated as safety issue: No ]
  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.

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.

• 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

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.