NCT07266753

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,418

participants targeted

Target at P75+ for phase_4

Timeline
94mo left

Started Feb 2026

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Feb 2026Dec 2033

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

March 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5.8 years

First QC Date

November 24, 2025

Last Update Submit

March 23, 2026

Conditions

Osteomyelitis - FootOsteomyelitis of the FootOsteomyelitis of Lower Extremities

Keywords

OsteomyelitisBone InfectionLower ExtremityOral beta-lactams versus non-beta-lactams

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 Weeks

Secondary Outcomes (10)

  • Secondary Effectiveness Outcomes

    24 Weeks

  • Secondary Effectiveness Outcomes

    24 weeks

  • Secondary Effectiveness Outcome

    24 weeks

  • Secondary Effectiveness Outcome

    24 weeks

  • Secondary Effectiveness Outcome

    24 weeks

  • +5 more secondary outcomes

Other Outcomes (3)

  • Feasibility Outcome

    24 weeks

  • Feasibility Outcome

    24 weeks

  • Feasibility Outcome

    24 weeks

Study Arms (2)

Oral Beta-Lactam Antibiotic

EXPERIMENTAL
Drug: Oral Beta-Lactam Antibiotic

Oral Non-Beta-Lactam Antibiotic

ACTIVE COMPARATOR
Drug: Oral Non-Beta-Lactam Antibiotic

Interventions

Oral Non-Beta-Lactam AntibioticDRUG

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.

Oral Non-Beta-Lactam Antibiotic
Oral Beta-Lactam AntibioticDRUG

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 Beta-Lactam Antibiotic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior enrolment in the OSTEO trial
  • Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM
  • No beta-lactam or non-beta-lactam option due to any of:
  • Allergy
  • Suspected or confirmed antimicrobial resistance
  • Medical contraindications
  • Non-modifiable drug-drug interaction risk
  • Need to receive combination antibiotic therapy with both beta-lactam and non-beta-lactam, with the exception of metronidazole and rifampin
  • Prior antibiotic treatment for the same infection in the past 6 months
  • Known pregnancy, planning to become pregnant during the study period, or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

NOT YET RECRUITING

Michael Garron Hospital

Toronto, Ontario, M4C 3E7, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Osteomyelitis

Interventions

Monobactams

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

beta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Christopher Kandel, MD

CONTACT

14164696252christopher.kandel@tehn.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

February 26, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2033

Last Updated

March 27, 2026

Record last verified: 2026-02

Locations

CA(3)