OsteomyelitisNCT06096012
Don't Treat Ghosts Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA
An observational study of Osteomyelitis, run by Methodist Health System at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- Anti-MRSA therapy
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 23 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Colette Ngo Ndjom, MS, 214-947-4681, mhsirb@mhd.com
Bethany Brauer, MPH, 217-947-4681, mhsirb@mhd.com
About this study
Official title: Don't Treat Ghosts: Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA
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.
- Conditions
- Osteomyelitis
- Being tested
- Anti-MRSA therapy
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-MRSA therapyDrug
Also called Anti-MRSA Antibiotics
chart review to determine the clinical outcomes of patients with osteomyelitis who were placed on definitive anti-MRSA treatment, despite no identified MRSA cultures.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start23 Jun 2023
- Primary completion23 Jun 2024 (estimated)
- Study completion23 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Crotty, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096012
- Sponsor's protocol ID
- 025.PHA.2023.A
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 36439590Hirschfeld 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Don't Treat Ghosts: Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA
- ClinicalTrials.gov ID
- NCT06096012
- Acronym / sponsor ID
- 025.PHA.2023.A
- Conditions
- Osteomyelitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Jun 2024 (estimated)
- Study completion
- 23 Jun 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- • Admission to any MHS hospital between April 1, 2017 and April 1, 2023
Key exclusion criteria (6 listed)
- • IV antibiotics for less than 24 hours inpatient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-MRSA therapyAlso: Anti-MRSA Antibioticschart review to determine the clinical outcomes of patients with osteomyelitis who were placed on definitive anti-MRSA treatment, despite no identified MRSA cultures. | Drug | – |
Primary outcome
Comparison of treatment
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 36439590Jha Y, Chaudhary K. Diagnosis and Treatment Modalities for Osteomyelitis. Cureus. 2022 Oct 26;14(10):e30713. doi: 10.7759/cureus.30713. eCollection 2022 Oct.
- Background: PubMed 31441894Hirschfeld 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Crotty, PharmD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bethany Brauer, MPH (214-947-4681 ext. 74681, MHSIRB@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of treatment (time frame: 180 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06096012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.