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

NCT ID: NCT06096012

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-23

Study Completion Date

2024-06-23

Brief Summary

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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

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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.

Conditions

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Osteomyelitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Anti-MRSA Antibiotics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Crotty, PharmD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bethany Brauer, MPH

Role: CONTACT

214-947-4681 ext. 74681

Colette Ngo Ndjom, MS

Role: CONTACT

214-947-4681

Facility Contacts

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Colette Ngo Ndjom, MS

Role: primary

214-947-4681

Bethany Brauer, MPH

Role: backup

217-947-4681

References

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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.

Reference Type BACKGROUND
PMID: 36439590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31441894 (View on PubMed)

Other Identifiers

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025.PHA.2023.A

Identifier Type: -

Identifier Source: org_study_id

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