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

Last updated: November 18, 2024
Sponsor: Methodist Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Osteomyelitis

Diabetes And Hypertension

Treatment

Omadacycline

Clinical Study ID

NCT04714411
014.PHA.2020.A
  • Ages > 18
  • All Genders

Study 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 osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to retrospective controls. Prospective enrollment will be continued until the sample size is achieved up to one year from start date (October 2020).

Secondary to slower than anticipated enrollment due to the COVID-19 pandemic and initial exclusion of AOM, following protocol amendment, patient enrollment will be continued until the sample size is achieved up to 18 months from amendment approval (anticipate April 2022 - October 2023). A historical matched case cohort (standard of care) at the two hospitals based on ICD10 codes associated with DFI [E11.(621, 622), E10.(621, 622); L97.(509, 521, 522, 523, 524, 529)], including subjects with AOM [M86.(08-09, 10, 16-19, 8X0, 8X7-8X9, 9) will be utilized for comparison.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female and male subjects will be eligible for inclusion if hospitalized, 18 years orolder, diagnosed with type 1 or 2 diabetes, and have DFI with the additionalclinical criteria as specified below:

  • Acute infection or worsening without systemic antimicrobials within theprevious 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 48hours prior to enrollment

  • Inclusion will be based on

  • Empiric coverage based on organisms suspected to be caused by susceptiblebacteria, if no culture identifies a specific organism; or

  • Confirmed susceptibility to omadacycline against any organism identified. Anysubject in which a pathogen resistant to omadacycline is identified will beexcluded from the study and antibiotics will be changed based on physiciandiscretion.

  • First episodes of AOM at qualifying site of infection will be eligible forinclusion 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

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 localactivity within the GI tract

  • Contraindication or hypersensitivity to omadacycline/tetracyclines

  • Unwilling or unable to participate in study-related procedures or visits

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Omadacycline
Phase:
Study Start date:
November 05, 2020
Estimated Completion Date:
August 18, 2025

Study 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). Omadacycline (Nuzyra®) is a FDA approved antibiotic for skin and skin structure infection and community-acquired pneumonia. This study is considered to be investigational because data is being collected on the use of Omadacycline for the treatment of DFI with or without AOM.

Connect with a study center

  • Methodist Charlton Medical Center

    Dallas, Texas 75237
    United States

    Site Not Available

  • Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Active - Recruiting

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