Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichael Garron Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Prior enrolment in the OSTEO trial
Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM
Allergy
Suspected or confirmed antimicrobial resistance
Trial design
Treatments tested in this trial
- Oral Beta-Lactam Antibiotic
- Oral Non-Beta-Lactam Antibiotic
Treatment groups
1,418 Participants
are divided into 2 treatment groupsSponsors and collaborators
Michael Garron Hospital
Lead sponsor
University Health Network, Toronto
Collaborator
Ottawa Hospital Research Institute
Collaborator
Source ClinicalTrials.gov