Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04714411
Study type Observational
Source Methodist Health System
Contact Crystee Cooper, DHEd
Phone 214-947-1281
Email ClinicalResearch@mhd.com
Status Recruiting
Phase
Start date November 5, 2020
Completion date August 18, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Recruiting NCT05613985 - PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers N/A
Recruiting NCT03964571 - Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients N/A
Completed NCT03230175 - Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01) Phase 2
Completed NCT05616351 - Antibiotic Therapy in Infections of the Diabetic Foot Syndrome
Recruiting NCT05948592 - Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection Phase 2
Completed NCT05243810 - EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers N/A
Recruiting NCT05610865 - Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers Phase 1
Recruiting NCT04450693 - Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) Phase 3
Recruiting NCT05369052 - Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) Phase 3
Completed NCT02723539 - A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI Phase 1
Completed NCT04440839 - Implementation of Telemedicine for Patient With Lower Extremity Wounds N/A
Withdrawn NCT04289948 - Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes Phase 1/Phase 2
Completed NCT03495349 - Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.
Completed NCT05564728 - Diabetes Footcare Companion App for Patients and Carers
Withdrawn NCT03354806 - Peripheral Analgesia in Painful Diabetic Neuropathy N/A
Completed NCT01590758 - Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers Phase 3
Completed NCT01594762 - Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers Phase 3
Active, not recruiting NCT05174806 - Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients Phase 2
Recruiting NCT04141787 - Ceftriaxone as Home IV for Staph Infections Phase 4