Don't Treat Ghosts Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA

Don't Treat Ghosts: Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA

Osteomyelitis is described as infection and inflammation of the long bone or bone marrow, often due to an open wound, operation, or invasive trauma.1 It is invasive and involves hematogenous seeding or contiguous spread of the infectious organism

Study Overview

• Status: Recruiting
• Conditions: Osteomyelitis
• Intervention / Treatment: Drug: Anti-MRSA therapy

Detailed Description

This disease can be classified by location of infection, extent of spread, chronicity, and source of infection.3,4 Osteomyelitis can be caused by a variety of organisms, most commonly gram-positive staphylococci.

Osteomyelitis is associated with a high rate of relapse, high disease burden, and high health care costs.3 Following confirmation of disease via imaging and histopathologic examination, treatment consists of antibiotic therapy and, often, surgical intervention.3,5,6 Treatment with antibiotic therapy is often administered for 4-6 weeks when surgical intervention is not performed.6 Antibiotic selection should be guided by microbiology and antimicrobial susceptibilities.4 Thirty to sixty percent of osteomyelitis cases are caused by Staphylococcus aureus.

• Study Type: Observational
• Enrollment (Estimated): 365

Contacts and Locations

• Study Contact: Name: Colette Ngo Ndjom, MS; Phone Number: 214-947-4681; Email: mhsirb@mhd.com
• Study Contact Backup: Name: Bethany Brauer, MPH; Phone Number: 74681 214-947-4681; Email: mhsirb@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Colette Ngo Ndjom, MS; Phone Number: 214-947-4681; Email: mhsirb@mhd.com
      • Contact: Bethany Brauer, MPH; Phone Number: 217-947-4681; Email: mhsirb@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to any MHS hospital between April 1, 2017 and April 1, 2023

• > 18 years of age
• Documented osteomyelitis location of the lower limb via ICD-10 code
• Documented imaging of lower limb osteomyelitis during index admission
• Planned intravenous (IV) antibiotics for at least 4 weeks

Description

Inclusion Criteria:

• • Admission to any MHS hospital between April 1, 2017 and April 1, 2023

  • > 18 years of age
  • Documented osteomyelitis location of the lower limb via ICD-10 code
  • Documented imaging of lower limb osteomyelitis during index admission
  • Planned intravenous (IV) antibiotics for at least 4 weeks

Exclusion Criteria:

• • IV antibiotics for less than 24 hours inpatient

  • Planned surgical intervention documented at admission
  • Patients receiving monotherapy with an anti-MRSA agent
  • Positive MRSA culture during index admission
  • Current outpatient antibiotic use on index admission
  • Repeated hospital admission during study period

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of treatment	the comparison of treatment failure between anti-MRSA therapy and no anti-MRSA therapy defined as a composite of hospital readmission for osteomyelitis within 180 days of antibiotic initiation	180 Days

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Matthew Crotty, PharmD, Methodist Dallas Medical Center

Publications and helpful links

General Publications

• Jha Y, Chaudhary K. Diagnosis and Treatment Modalities for Osteomyelitis. Cureus. 2022 Oct 26;14(10):e30713. doi: 10.7759/cureus.30713. eCollection 2022 Oct.
• Hirschfeld CB, Kapadia SN, Bryan J, Jannat-Khah DP, May B, Vielemeyer O, Esquivel EL. Impact of diagnostic bone biopsies on the management of non-vertebral osteomyelitis: A retrospective cohort study. Medicine (Baltimore). 2019 Aug;98(34):e16954. doi: 10.1097/MD.0000000000016954.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): June 23, 2024
• Study Completion (Estimated): June 23, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Osteomyelitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 025.PHA.2023.A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at scientific meetings and/or publication in Open Access Journals.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Clinical trials portal or CRI MHS
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No