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

Osteomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096012
• Other study ID #: 025.PHA.2023.A
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: June 23, 2024

Study information

• Verified date: August 2023
• Source: Methodist Health System
• Contact: Bethany Brauer, MPH
• Phone: 214-947-4681
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 365
• Est. completion date: June 23, 2024
• Est. primary completion date: June 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteomyelitis

Intervention

Drug:
• Anti-MRSA therapy
chart review to determine the clinical outcomes of patients with osteomyelitis who were placed on definitive anti-MRSA treatment, despite no identified MRSA cultures.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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