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

Recruiting

• Conditions: Osteomyelitis

• Registration Number: NCT06096012
• Lead Sponsor: Methodist Health System

Brief Summary

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

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 Timeline

• Study Start: 2023-06-23
• Status Verified: 2023-08
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-06-23
• Study Completion: 2024-06-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 365

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of treatment	180 Days	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

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States