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

Launched by METHODIST HEALTH SYSTEM · Jan 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called omadacycline for treating diabetic foot infections (DFI) and acute osteomyelitis (AOM) in hospitalized patients. The goal is to see how safe and effective omadacycline is for people with moderate to severe infections, especially since these patients are at high risk for developing complications. The study is being conducted at two hospitals and will compare patients taking omadacycline to those who received standard care in the past. The trial aims to enroll participants until a specific number of patients is reached, which is expected to be completed by late 2023.

To be eligible for this trial, participants must be at least 18 years old, hospitalized with type 1 or type 2 diabetes, and diagnosed with a diabetic foot infection that meets certain criteria, such as having an infected ulcer at or below the ankle. They should not have received any systemic antibiotics for at least 48 hours before joining the study. Participants will receive the study medication and be monitored closely throughout the trial. It’s important to know that individuals with certain conditions, such as chronic osteomyelitis or specific infections resistant to omadacycline, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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