New antibiotic could be safer for diabetic foot infections

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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