Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

This is a year-long study with planned enrollment of 57 patients (in addition to 114 historical control patients) evaluating the use of omadacycline for treatment of diabetic foot infections (DFI). Omadacycline (Nuzyra®) is a FDA approved antibiotic for skin and skin structure infection and community-acquired pneumonia. This study is considered to be investigational because data is being collected on the use of Omadacycline for the treatment of DFI with or without AOM.

Inclusion criteria

• Female and male subjects will be eligible for inclusion if hospitalized, 18 years or older, diagnosed with type 1 or 2 diabetes, and have DFI with the additional clinical criteria as specified below:

• Acute infection or worsening without systemic antimicrobials within the previous 14 days
• At least one full or partial thickness-infected ulcer at or below the ankle AND
• Purulent drainage OR
• Two of the following:

• Erythema
• Local edema
• Fluctuance
• Induration
• Increased local warmth
• Fever
• No systemic antimicrobials with current hospital admission for more than 48 hours prior to enrollment
• Inclusion will be based on

• Empiric coverage based on organisms suspected to be caused by susceptible bacteria, if no culture identifies a specific organism; or
• Confirmed susceptibility to omadacycline against any organism identified. Any subject in which a pathogen resistant to omadacycline is identified will be excluded from the study and antibiotics will be changed based on physician discretion.

• First episodes of AOM at qualifying site of infection will be eligible for inclusion with any of the following criteria confirming the diagnosis:

• Imaging (X-ray or MRI) confirmation of acute osteomyelitis
• Pathology (bone biopsy/culture)
• Not currently enrolled in any other clinical trial
• Provides informed consent
• Likely to be compliant with all study-related procedures and visits

Exclusion criteria

• Age less than 18 years
• Pregnant women
• Chronic osteomyelitis

• Osteomyelitis of the same site previously treated with antibiotics
• Documented presence of osteomyelitis more than 2 weeks prior to index admission
• Necrotic or dead bone identified by pathology
• Unclear chronicity of infection (if unable to determine acute osteomyelitis)
• Has any gangrenous ulcers or necrotizing fasciitis
• Has a pathogen known to be resistant to omadacycline
• Administration of additional systemic antibiotics in combination with omadacycline, not including topical routes or oral vancomycin/fidaxomicin given their local activity within the GI tract
• Contraindication or hypersensitivity to omadacycline/tetracyclines
• Unwilling or unable to participate in study-related procedures or visits