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

Phase 4Not Yet RecruitingNCT07266753

Michael Garron Hospital1,418 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,418

Conditions

Osteomyelitis of Lower Extremities Osteomyelitis - Foot Osteomyelitis of the Foot

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary Effectiveness Outcomes

Cure (defined by meeting the criteria of: alive, not currently receiving antibiotics, no antibiotic switch from the assigned regimen and no surgical amputation)

Time frame: 24 Weeks

Secondary Outcomes

Secondary Effectiveness Outcomes

The number of participant deaths.

Time frame: 24 Weeks

Secondary Effectiveness Outcomes

Proportion of participants with an antibiotic switch (oral or IV)

Time frame: 24 weeks