Status:
RECRUITING
Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
Lead Sponsor:
Methodist Health System
Conditions:
Diabetic Foot Infection
Eligibility:
All Genders
18+ years
Brief Summary
This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyeli...
Detailed Description
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). Om...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 18 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04714411
Start Date
November 5 2020
End Date
August 18 2025
Last Update
November 20 2024
Active Locations (2)
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1
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
2
Methodist Charlton Medical Center
Dallas, Texas, United States, 75237