Clinical trial NCT06096012: Don't Treat Ghosts Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA
Official title: Don't Treat Ghosts: Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteomyelitis
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of treatment
timeFrame: 180 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Matthew Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.