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

Who can take part

• 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

Who cannot take part

• 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)
• Contraindication or hypersensitivity to omadacycline/tetracyclines
• Age less than 18 years
• Pregnant women
• 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
• Unwilling or unable to participate in study-related procedures or visits