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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult (\> 18 years old)

• OM of the lower extremity (below the knee) as determined by the treating healthcare provider (clinically and/or radiographically)

• Expected duration of treatment at least 28 additional days of antibiotic therapy for the infection episode, from the time of enrolment

• Treating health care team has already transitioned or is willing to transition to oral antibiotic therapy for the remainder of the treatment duration

Locations
Other Locations
Canada
Ottawa Hospital
NOT_YET_RECRUITING
Ottawa
Michael Garron Hospital
RECRUITING
Toronto
University Health Network
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Christopher Kandel, MD
christopher.kandel@tehn.ca
14164696252
Time Frame
Start Date: 2026-02-26
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 1418
Treatments
Experimental: Oral Beta-Lactam Antibiotic
Active_comparator: Oral Non-Beta-Lactam Antibiotic
Related Therapeutic Areas
Sponsors
Collaborators: University Health Network, Toronto, Ottawa Hospital Research Institute
Leads: Michael Garron Hospital

This content was sourced from clinicaltrials.gov

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