Recruiting

Beta-Lactam & Non-Beta-Lactam

Sponsor:

Michael Garron Hospital

Code:

NCT07266753

Conditions

Osteomyelitis of Lower Extremities

Osteomyelitis - Foot

Osteomyelitis of the Foot

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral Beta-Lactam Antibiotic

Oral Non-Beta-Lactam Antibiotic

Study Details

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.

Conditions

Osteomyelitis of Lower Extremities

Osteomyelitis - Foot

Osteomyelitis of the Foot

Study ID

NCT07266753

Start date

Feb 26, 2026

Status verified date

Feb, 2026

Completion date

Dec 31, 2033

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1418 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral Beta-Lactam Antibiotic

active comparator: Oral Non-Beta-Lactam Antibiotic

Interventions

Oral 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.

Oral 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.

Primary outcome measure

  • Primary Effectiveness Outcomes [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

Christopher Kandel, MD

14164696252christopher.kandel@tehn.ca

Locations

Michael Garron Hospital

Recruiting

Toronto, Ontario, Canada, M4C 3E7

Contacts

Christopher Kandel, MD

4164696252christopher.kandel@tehn.ca

Mazen Almatry, MBA

+16473940003Mazen.Almatry@tehn.ca

More Information

Sponsor

Michael Garron Hospital

Last update posted

Mar 27, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael Garron Hospital on 2026-03-27.