ClinicalTrials.gg
RecruitingNCT06096012Updated Oct 23, 2023

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

An observational study in Osteomyelitis, sponsored by Methodist Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Methodist Health System · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
365
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Osteomyelitis

Browse trials for

03

In context

Osteomyelitis

105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.

This study's planned enrollment of 365 is above the median of 86 across 41 observational studies indexed under Osteomyelitis.

Browse Osteomyelitis studies →

Lead sponsor

Methodist Health System is the lead sponsor of 170 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
365 participants (estimated)
Patient registry
No

Interventions

  • DrugAnti-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.

    Also known as: Anti-MRSA Antibiotics

06

What researchers measure

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

    Time frame: 180 Days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 36439590 ↗
  • 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. PubMed 31441894 ↗

Individual participant data

Plan to share: Yes — The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at scientific meetings and/or publication in Open Access Journals.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: 2 years

Access criteria: Clinical trials portal or CRI MHS

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Jun 2024, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2023
First posted
Oct 23, 2023
StartActual
Jun 23, 2023
Primary completionEst.
Jun 23, 2024
CompletionEst.
Jun 23, 2024
Last update
Oct 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06096012
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Jun 23, 2023
Primary completion
Jun 23, 2024 (estimated)
Completion
Jun 23, 2024 (estimated)
Last update
Oct 23, 2023

Study contacts

Bethany Brauer, MPH
Contact
MHSIRB@mhd.com
214-947-4681 ext. 74681
Colette Ngo Ndjom, MS
Contact
mhsirb@mhd.com
214-947-4681
Matthew Crotty, PharmD
principal investigator · The Methodist Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion