Evaluating omadacycline for treating diabetic foot infections

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

This study is testing if omadacycline is a safe and effective treatment for people in the hospital with serious diabetic foot infections and bone infections compared to standard care.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Methodist Health System (Academic / other)
• Locations: 2 sites (Dallas, Texas and 1 other locations)
• Trial ID: NCT04714411 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and efficacy of omadacycline in hospitalized patients with moderate to severe diabetic foot infections (DFI) and acute osteomyelitis (AOM). It involves a prospective, open-label design across two centers, with enrollment of 57 patients alongside 114 historical controls. The study will collect data on the outcomes of patients treated with omadacycline compared to those receiving standard care, focusing on the risk of complications such as Clostridium difficile infection and acute kidney injury.

Who should consider this trial

Good fit: Ideal candidates include hospitalized adults aged 18 and older with type 1 or 2 diabetes diagnosed with moderate to severe diabetic foot infections.

Not a fit: Patients with infections caused by pathogens resistant to omadacycline will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from diabetic foot infections.

How similar studies have performed: While omadacycline has been approved for other infections, this specific application for diabetic foot infections is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Dallas, Texas and 1 other locations

• Methodist Dallas Medical Center — Dallas, Texas, United States (Recruiting)
• Methodist Charlton Medical Center — Dallas, Texas, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Matthew Crotty, PharmD — Methodist Health System
• Study coordinator: Crystee Cooper, DHEd

Conditions Diabetic Foot Infection