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

Sponsor

Methodist Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT06096012

Collaborator

(none)

365

Enrollment

Location

Anticipated Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Osteomyelitis	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 Design

Study Type:

Observational

Anticipated Enrollment :

365 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 23, 2023

Anticipated Primary Completion Date :

Jun 23, 2024

Anticipated Study Completion Date :

Jun 23, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

Methodist Health System

Investigators

Principal Investigator: Matthew Crotty, PharmD, Methodist Dallas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Methodist Health System

ClinicalTrials.gov Identifier:

NCT06096012

Other Study ID Numbers:

025.PHA.2023.A

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteomyelitis

Anti-Bacterial Agents

Study Results

No Results Posted as of Oct 23, 2023