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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| Ottawa Hospital Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Beta-Lactam Antibiotic | Experimental |
| |
| Oral Non-Beta-Lactam Antibiotic | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Beta-Lactam Antibiotic | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness Outcomes | The number of participant deaths. | 24 Weeks |
| Secondary Effectiveness Outcomes | Proportion of participants with an antibiotic switch (oral or IV) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Outcome | The proportion of potentially eligible participants approached for the trial who provide consent and are randomized (recruitment rate) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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
Known pregnancy, planning to become pregnant during the study period, or breastfeeding
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kandel, MD | Contact | 14164696252 | christopher.kandel@tehn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital | Not yet recruiting | Ottawa | Ontario | K1Y 4E9 | Canada |
Awaiting Research Ethics Board approval of the study.
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| ID | Term |
|---|---|
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008997 | Monobactams |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 |
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| Oral Non-Beta-Lactam Antibiotic | Drug | 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. |
|
| 24 weeks |
| Secondary Effectiveness Outcome | Number and level of amputations | 24 weeks |
| Secondary Effectiveness Outcome | Number of debridement operations | 24 weeks |
| Secondary Effectiveness Outcome | Proportion of participants receiving chronic antibiotics for infection suppression | 24 weeks |
| Secondary Effectiveness Outcome | Total duration of antibiotics (oral and IV) for the initial treatment episode | 24 weeks |
| Secondary Effectiveness Outcome | Number and type of antibiotic-related adverse events | 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 | 24 weeks |
| Secondary Effectiveness Outcome | Wound colonization with a pathogen of interest | 24 weeks |
| Secondary Effectiveness Outcome | Any positive clinical bacterial culture | 52 weeks |
| 24 weeks |
| Feasibility Outcome | The proportion of participants from whom the primary effectiveness outcome is obtained (complete outcome ascertainment rate). | 24 weeks |
| Michael Garron Hospital | Recruiting | Toronto | Ontario | M4C 3E7 | Canada |
|
| University Health Network | Not yet recruiting | Toronto | Ontario | M5G 2C4 | Canada |
|
| Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |