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

NCT06096012 | Unknown

• 1 other identifier: 025.PHA.2023.A
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

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

Conditions

Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Anti-MRSA therapy DRUG

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

Also known as: Anti-MRSA Antibiotics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 36439590 BACKGROUND

• 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.

  PMID: 31441894 BACKGROUND

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Matthew Crotty, PharmD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany Brauer, MPH

CONTACT

214-947-4681; MHSIRB@mhd.com

Colette Ngo Ndjom, MS

CONTACT

214-947-4681; mhsirb@mhd.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: June 23, 2023
• Primary Completion: June 23, 2024
• Study Completion: June 23, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2 years
• Access Criteria: Clinical trials portal or CRI MHS

Locations

US (1)