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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07266753

Acronym

OSTEO

Enrollment

1418

Registered

2025-12-05

Start date

2026-02-26

Completion date

2033-12-31

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteomyelitis - Foot, Osteomyelitis of Lower Extremities, Osteomyelitis of the Foot

Keywords

Osteomyelitis, Bone Infection, Lower Extremity, Oral beta-lactams versus non-beta-lactams

Brief 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.

Interventions

DRUGOral 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.

DRUGOral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Effectiveness Outcomes	24 Weeks	Cure (defined by meeting the criteria of: alive, not currently receiving antibiotics, no antibiotic switch from the assigned regimen and no surgical amputation)

Secondary

Measure	Time frame	Description
Secondary Effectiveness Outcomes	24 Weeks	The number of participant deaths.
Secondary Effectiveness Outcome	24 weeks	Number and level of amputations

Countries

Canada

Contacts

CONTACTChristopher Kandel, MD

christopher.kandel@tehn.ca14164696252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026