CompletedNot Applicable

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

United States42 participantsStarted 2020-11-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 visi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AKI based on RIFLE criteria

Timeframe: Sept 2020 - Aug 2021

Clostridioides difficile Infection

Timeframe: Sept 2020 - Aug 2021

Trial details

NCT IDNCT04714411

SponsorMethodist Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-14

View on ClinicalTrials.gov More Diabetic Foot Infection trials