Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot

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.

Inclusion Criteria:

1. Adult (> 18 years old)
2. OM of the lower extremity (below the knee) as determined by the treating healthcare provider (clinically and/or radiographically)
3. Expected duration of treatment at least 28 additional days of antibiotic therapy for the infection episode, from the time of enrolment
4. Treating health care team has already transitioned or is willing to transition to oral antibiotic therapy for the remainder of the treatment duration

Exclusion Criteria:

1. Prior enrolment in the OSTEO trial

2. Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM

3. No beta-lactam or non-beta-lactam option due to any of:

   1. Allergy
   2. Suspected or confirmed antimicrobial resistance
   3. Medical contraindications
   4. Non-modifiable drug-drug interaction risk

4. Need to receive combination antibiotic therapy with both beta-lactam and non-beta-lactam, with the exception of metronidazole and rifampin

5. Prior antibiotic treatment for the same infection in the past 6 months

6. Known pregnancy, planning to become pregnant during the study period, or breastfeeding