Osteomyelitis of Lower ExtremitiesPhase 4OSTEONCT07266753
Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot
A Phase 4 study testing Oral Beta-Lactam Antibiotic and Oral Non-Beta-Lactam Antibiotic in people with Osteomyelitis of Lower Extremities and Osteomyelitis - Foot, run by Michael Garron Hospital at 3 sites in Canada.
Trial summary
The goal of this clinical trial is to compare different classes of oral antibiotics (beta-lactam and non-beta-lactam antibiotics) for the treatment of bone infections of the leg and foot. The hypothesis is that oral beta-lactam antibiotics work as well as oral non-beta-lactam antibiotics to treat these infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis of Lower Extremities, Osteomyelitis - Foot, Osteomyelitis of the Foot
- What is being tested?
- Oral Beta-Lactam Antibiotic and Oral Non-Beta-Lactam Antibiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,418 participants
- Where
- 3 sitesCanada
- Study dates
- 26 Feb 2026to 31 Dec 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 years old)
- OM of the lower extremity (below the knee) as determined by the treating healthcare provider (clinically and/or radiographically)
- Expected duration of treatment at least 28 additional days of antibiotic therapy for the infection episode, from the time of enrolment
- Treating health care team has already transitioned or is willing to transition to oral antibiotic therapy for the remainder of the treatment duration
Who cannot join
- Prior enrolment in the OSTEO trial
- Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM
- No beta-lactam or non-beta-lactam option due to any of:
- Allergy
- Suspected or confirmed antimicrobial resistance
- Medical contraindications
Show all 10Show fewer
- Non-modifiable drug-drug interaction risk
- Need to receive combination antibiotic therapy with both beta-lactam and non-beta-lactam, with the exception of metronidazole and rifampin
- Prior antibiotic treatment for the same infection in the past 6 months
- Known pregnancy, planning to become pregnant during the study period, or breastfeeding
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Not yet recruiting
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Derek MacFadden, MD, dmacfadden@toh.ca
- Recruiting
Michael Garron Hospital
Toronto, Ontario, M4C 3E7
Christopher Kandel, MD, 4164696252, christopher.kandel@tehn.ca
Mazen Almatry, MBA, +16473940003, Mazen.Almatry@tehn.ca
- Not yet recruiting
University Health Network
Toronto, Ontario, M5G 2C4
bryan.coburn@uhn.ca
About this study
Official title: Oral Beta-lactams Versus Non-beta-lactamS for Treatment of Lower Extremity Osteomyelitis
The goal of this clinical trial is to compare different classes of oral antibiotics (beta-lactam and non-beta-lactam antibiotics) for the treatment of bone infections of the leg and foot. The hypothesis is that oral beta-lactam antibiotics work as well as oral non-beta-lactam antibiotics to treat these infections. The first step is to assess whether it is possible to perform the trial by determining whether participants can be recruited and followed successfully. If the trial is proven to be possible, it will be expanded to ensure an answer to whether the two antibiotic classes work as well for the treatment of bone infections of the leg and foot.
- Being tested
- Oral Beta-Lactam Antibiotic, Oral Non-Beta-Lactam Antibiotic
- Keywords
- Osteomyelitis, Bone Infection, Lower Extremity, Oral beta-lactams versus non-beta-lactams
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Beta-Lactam AntibioticDrug
Participants in this arm are randomized to receive an oral antibiotic from the beta-lactam class (e.g., penicillins or cephalosporins) for the treatment of lower extremity osteomyelitis.
Oral Non-Beta-Lactam AntibioticDrug
Participants in this arm are randomized to receive an oral antibiotic from the non-beta-lactam class (e.g., fluoroquinolones, lincosamides, sulfonamides) for the treatment of lower extremity osteomyelitis.
| Study group | Role | What they receive |
|---|---|---|
| Oral Beta-Lactam Antibiotic | Experimental | Not described Receives: Drug: Oral Beta-Lactam Antibiotic |
| Oral Non-Beta-Lactam Antibiotic | Active comparator | Not described Receives: Drug: Oral Non-Beta-Lactam Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Outcomes
Cure (defined by meeting the criteria of: alive, not currently receiving antibiotics, no antibiotic switch from the assigned regimen and no surgical amputation)
Measured: 24 Weeks
Secondary outcomes (10)
Secondary Effectiveness Outcomes
The number of participant deaths.
Measured: 24 Weeks
Secondary Effectiveness Outcomes
Proportion of participants with an antibiotic switch (oral or IV)
Measured: 24 weeks
Secondary Effectiveness Outcome
Number and level of amputations
Measured: 24 weeks
Secondary Effectiveness Outcome
Number of debridement operations
Measured: 24 weeks
Secondary Effectiveness Outcome
Proportion of participants receiving chronic antibiotics for infection suppression
Measured: 24 weeks
Secondary Effectiveness Outcome
Total duration of antibiotics (oral and IV) for the initial treatment episode
Measured: 24 weeks
Secondary Effectiveness Outcome
Number and type of antibiotic-related adverse events
Measured: 24 weeks
Secondary Effectiveness Outcome
Quality of life measurement at 24 weeks (determined by EQ-5D questionnaire) The EQ-5D is a standardized instrument for measuring health-related quality of life. Scores range from 0 (worst possible health state) to 1 (best possible health state), with higher scores indicating better
Measured: 24 weeks
Secondary Effectiveness Outcome
Wound colonization with a pathogen of interest
Measured: 24 weeks
Secondary Effectiveness Outcome
Any positive clinical bacterial culture
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start26 Feb 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis of Lower ExtremitiesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Garron Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266753
- Sponsor's protocol ID
- IDRU-INT-2024-004
- Acronym
- OSTEO
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Awaiting Research Ethics Board approval of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Beta-lactams Versus Non-beta-lactamS for Treatment of Lower Extremity Osteomyelitis
- ClinicalTrials.gov ID
- NCT07266753
- Acronym / sponsor ID
- OSTEO / IDRU-INT-2024-004
- Keywords
- Osteomyelitis, Bone Infection, Lower Extremity, Oral beta-lactams versus non-beta-lactams
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,418 participants (estimated)
- Lead sponsor
- Michael Garron HospitalUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Ottawa Hospital Research Institute
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 5 Dec 2025 (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.
The goal of this clinical trial is to compare different classes of oral antibiotics (beta-lactam and non-beta-lactam antibiotics) for the treatment of bone infections of the leg and foot. The hypothesis is that oral beta-lactam antibiotics work as well as oral non-beta-lactam antibiotics to treat these infections. The first step is to assess whether it is possible to perform the trial by determining whether participants can be recruited and followed successfully. If the trial is proven to be possible, it will be expanded to ensure an answer to whether the two antibiotic classes work as well for the treatment of bone infections of the leg and foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Beta-Lactam Antibiotic | Experimental | Drug: Oral Beta-Lactam Antibiotic |
| Oral Non-Beta-Lactam Antibiotic | Active comparator | Drug: Oral Non-Beta-Lactam Antibiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (> 18 years old)
- OM of the lower extremity (below the knee) as determined by the treating healthcare provider (clinically and/or radiographically)
- Expected duration of treatment at least 28 additional days of antibiotic therapy for the infection episode, from the time of enrolment
- Treating health care team has already transitioned or is willing to transition to oral antibiotic therapy for the remainder of the treatment duration
Key exclusion criteria (10 listed)
- Prior enrolment in the OSTEO trial
- Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM
- No beta-lactam or non-beta-lactam option due to any of:
- Need to receive combination antibiotic therapy with both beta-lactam and non-beta-lactam, with the exception of metronidazole and rifampin
- Prior antibiotic treatment for the same infection in the past 6 months
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 |
|---|---|---|
| Oral Beta-Lactam AntibioticParticipants in this arm are randomized to receive an oral antibiotic from the beta-lactam class (e.g., penicillins or cephalosporins) for the treatment of lower extremity osteomyelitis. | Drug | Oral Beta-Lactam Antibiotic |
| Oral Non-Beta-Lactam AntibioticParticipants in this arm are randomized to receive an oral antibiotic from the non-beta-lactam class (e.g., fluoroquinolones, lincosamides, sulfonamides) for the treatment of lower extremity osteomyelitis. | Drug | Oral Non-Beta-Lactam Antibiotic |
Primary outcome
Primary Effectiveness Outcomes
Time frame: 24 Weeks
Cure (defined by meeting the criteria of: alive, not currently receiving antibiotics, no antibiotic switch from the assigned regimen and no surgical amputation)
10 secondary outcomes
Secondary Effectiveness Outcomes
Time frame: 24 Weeks
Secondary Effectiveness Outcomes
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 24 weeks
Secondary Effectiveness Outcome
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. Awaiting Research Ethics Board approval of the study.
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Osteomyelitis of Lower Extremities
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Beta-Lactam Antibiotic and Oral Non-Beta-Lactam Antibiotic in people with Osteomyelitis of Lower Extremities and Osteomyelitis - Foot, run by Michael Garron Hospital at 3 sites in Canada.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Kandel, MD (14164696252, christopher.kandel@tehn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Outcomes (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.