A Phase 4 interventional study of Oral Beta-Lactam Antibiotic and Oral Non-Beta-Lactam Antibiotic in Osteomyelitis of Lower Extremities, Osteomyelitis - Foot and Osteomyelitis of the Foot, sponsored by Michael Garron Hospital. Recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Michael Garron Hospital · Phase 4, Interventional, and Treatment
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 1,418 is above the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Michael Garron Hospital is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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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.
Exclusion Criteria:
No beta-lactam or non-beta-lactam option due to any of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Oral Beta-Lactam Antibiotic
Drug: Oral Non-Beta-Lactam Antibiotic
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.
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.
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)
Time frame: 24 Weeks
Secondary Effectiveness Outcomes
The number of participant deaths.
Time frame: 24 Weeks
Secondary Effectiveness Outcomes
Proportion of participants with an antibiotic switch (oral or IV)
Time frame: 24 weeks
Secondary Effectiveness Outcome
Number and level of amputations
Time frame: 24 weeks
Secondary Effectiveness Outcome
Number of debridement operations
Time frame: 24 weeks
Secondary Effectiveness Outcome
Proportion of participants receiving chronic antibiotics for infection suppression
Time frame: 24 weeks
Secondary Effectiveness Outcome
Total duration of antibiotics (oral and IV) for the initial treatment episode
Time frame: 24 weeks
Secondary Effectiveness Outcome
Number and type of antibiotic-related adverse events
Time frame: 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
Time frame: 24 weeks
Secondary Effectiveness Outcome
Wound colonization with a pathogen of interest
Time frame: 24 weeks
Secondary Effectiveness Outcome
Any positive clinical bacterial culture
Time frame: 52 weeks
Feasibility Outcome
The proportion of potentially eligible participants approached for the trial who provide consent and are randomized (recruitment rate)
Time frame: 24 weeks
Feasibility Outcome
The proportion of participants who receive an initial dose of an antibiotic from the class to which they were randomly allocated (adherence rate)
Time frame: 24 weeks
Feasibility Outcome
The proportion of participants from whom the primary effectiveness outcome is obtained (complete outcome ascertainment rate).
Time frame: 24 weeks
Plan to share: Undecided — Awaiting Research Ethics Board approval of the study.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2031, 70 months after the start.
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Michael Garron Hospital