Comparing oral beta-lactam and non-beta-lactam antibiotics for leg and foot bone infections

Oral Beta-lactams Versus Non-beta-lactamS for Treatment of Lower Extremity Osteomyelitis

This trial will test whether oral beta-lactam antibiotics work as well as other oral antibiotics for adults with bone infections of the lower leg or foot.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1418 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Michael Garron Hospital (other)
• Locations: 3 sites (Ottawa, Ontario and 2 other locations)
• Trial ID: NCT07266753 on ClinicalTrials.gov

What this trial studies

This Phase 4 trial will enroll adults with clinician-diagnosed osteomyelitis below the knee who are being transitioned to or starting at least 28 more days of oral antibiotic therapy. Participants will receive either an oral beta-lactam or an oral non-beta-lactam antibiotic and will be followed to determine recruitment feasibility, treatment adherence, clinical outcomes, and safety. The initial phase focuses on whether participants can be recruited and followed successfully, with the possibility of expanding enrollment to provide a definitive comparison of the two drug classes. Outcomes will include measures of infection resolution, recurrence, adverse events, and need for further interventions.

Who should consider this trial

Good fit: Adults over 18 with clinician-diagnosed osteomyelitis of the lower extremity who can be treated with oral antibiotics and need at least 28 additional days of therapy are the intended participants.

Not a fit: Patients who cannot take either class because of allergy, resistance, medical contraindication, irreversible drug interactions, who require combination therapy with both classes, or who have already had more than 14 days of uninterrupted antibiotics for the current episode are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the trial could expand effective, convenient, and potentially lower-cost oral antibiotic options for people with lower-extremity bone infections and support more targeted antibiotic use.

How similar studies have performed: Previous trials have shown that oral antibiotics can be as effective as intravenous therapy for bone infections (for example, OVIVA), but direct head-to-head comparisons of oral beta-lactams versus non-beta-lactams remain limited.

Eligibility criteria

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

Where this trial is running

Ottawa, Ontario and 2 other locations

• Ottawa Hospital — Ottawa, Ontario, Canada (NOT_YET_RECRUITING)
• Michael Garron Hospital — Toronto, Ontario, Canada (RECRUITING)
• University Health Network — Toronto, Ontario, Canada (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Christopher Kandel, MD

Conditions: Osteomyelitis of Lower Extremities, Osteomyelitis - Foot, Osteomyelitis of the Foot, Osteomyelitis, Bone Infection, Lower Extremity, Oral beta-lactams versus non-beta-lactams