Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot (OSTEO)

Michael Garron Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Osteomyelitis of the Foot; Osteomyelitis - Foot; Osteomyelitis of Lower Extremities

Treatments: Drug: Oral Beta-Lactam Antibiotic; Drug: Oral Non-Beta-Lactam Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT07266753

IDRU-INT-2024-004

Details and patient eligibility

About

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.

Enrollment: 1,418 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,418 participants in 2 patient groups

Oral Beta-Lactam Antibiotic

Experimental group

Treatment:

Drug: Oral Beta-Lactam Antibiotic

Oral Non-Beta-Lactam Antibiotic

Active Comparator group

Treatment:

Drug: Oral Non-Beta-Lactam Antibiotic