NCT07266753

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,418 (estimated)
• Sponsor: Michael Garron Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Osteomyelitis of Lower Extremities
• Osteomyelitis - Foot
• Osteomyelitis of the Foot

Interventions

Type	Name	Description
DRUG	Oral 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.
DRUG	Oral Non-Beta-Lactam Antibiotic	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.

Timeline

• Start date: 2026-02-26
• Primary completion: 2031-12-31
• Completion: 2033-12-31
• First posted: 2025-12-05
• Last updated: 2026-03-27

Locations

3 sites across 1 country: Canada