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

Sponsor

Methodist Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT04714411

Collaborator

(none)

100

Enrollment

Locations

23.9

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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 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 form start date (anticipate August 2020 - August 2021).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Infection	Drug: Omadacycline

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). 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 5, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Retrospective Cohort A historical matched case cohort
Prospective Cohort Subjects will be screened daily via review of the EMR reports of inpatient admissions. Those receiving antibiotics with a notated source of skin/soft tissue infection will be further reviewed to determine if the source of infection is a DFI without suspected or confirmed osteomyelitis.	Drug: Omadacycline Omadacycline monotgherapy

Arm

Intervention/Treatment

Retrospective Cohort

A historical matched case cohort

Prospective Cohort

Subjects will be screened daily via review of the EMR reports of inpatient admissions. Those receiving antibiotics with a notated source of skin/soft tissue infection will be further reviewed to determine if the source of infection is a DFI without suspected or confirmed osteomyelitis.

Drug: Omadacycline

Omadacycline monotgherapy

Outcome Measures

Primary Outcome Measures

AKI based on RIFLE criteria [Sept 2020 - Aug 2021]
Risk, injury, failure, loss and ESRD
Clostridioides difficile Infection [Sept 2020 - Aug 2021]
Frequency of Clostridioides difficile Infections while taking Omadacycline compared to other antibiotics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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
Confirmed or high suspicion of osteomyelitis at the time of enrollment, as evidenced by:
Imaging (X-ray or MRI); imaging will be completed in order to rule out osteomyelitis in subjects with any of the following conditions:
Soft tissue sinus tract
Red, swollen (sausage) toe and ulcer
Deep ulcer
Ulcer over a bony prominence
Pathology (bone biopsy/culture)
Visible exposed bone
Positive probe-to-bone test (negative predictive value of 98 percent) 25
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203
2	Methodist Charlton Medical Center	Dallas	Texas	United States	75237

Sponsors and Collaborators

Methodist Health System

Investigators

Principal Investigator: Matthew Crotty, PharmD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Methodist Health System

ClinicalTrials.gov Identifier:

NCT04714411

Other Study ID Numbers:

014.PHA.2020.A

First Posted:

Jan 19, 2021

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Focal Infection

Diabetic Foot

Study Results

No Results Posted as of Nov 17, 2021