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NCT Number: NCT07266753

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

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.

Recruiting

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Key information

Conditions

Osteomyelitis of Lower Extremities Bone Diseases Bone Diseases, Infectious Infections Musculoskeletal Diseases Osteomyelitis Osteomyelitis - Foot Osteomyelitis of the Foot

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ottawa Hospital, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Oral Beta-Lactam Antibiotic

Drug

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

Drug

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 outcomes

  1. Primary Effectiveness Outcomes

    Time frame: 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 outcomes

  1. Secondary Effectiveness Outcomes

    Time frame: 24 Weeks

    The number of participant deaths.

  2. Secondary Effectiveness Outcomes

    Time frame: 24 weeks

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

  3. Secondary Effectiveness Outcome

    Time frame: 24 weeks

    Number and level of amputations

  4. Secondary Effectiveness Outcome

    Time frame: 24 weeks

    Number of debridement operations

  5. Secondary Effectiveness Outcome

    Time frame: 24 weeks

    Proportion of participants receiving chronic antibiotics for infection suppression

  6. Secondary Effectiveness Outcome

    Time frame: 24 weeks

    Total duration of antibiotics (oral and IV) for the initial treatment episode

  7. Secondary Effectiveness Outcome

    Time frame: 24 weeks

    Number and type of antibiotic-related adverse events

  8. Secondary Effectiveness Outcome

    Time frame: 24 weeks

    Quality of life measurement at 24 weeks (determined by EQ-5D questionnaire) The EQ-5D is a standardized instrument for measuring health-related quality of life. Scores range from 0 (worst possible health state) to 1 (best possible health state), with higher scores indicating better

  9. Secondary Effectiveness Outcome

    Time frame: 24 weeks

    Wound colonization with a pathogen of interest

  10. Secondary Effectiveness Outcome

    Time frame: 52 weeks

    Any positive clinical bacterial culture

Other outcomes

  1. Feasibility Outcome

    Time frame: 24 weeks

    The proportion of potentially eligible participants approached for the trial who provide consent and are randomized (recruitment rate)

  2. Feasibility Outcome

    Time frame: 24 weeks

    The proportion of participants who receive an initial dose of an antibiotic from the class to which they were randomly allocated (adherence rate)

  3. Feasibility Outcome

    Time frame: 24 weeks

    The proportion of participants from whom the primary effectiveness outcome is obtained (complete outcome ascertainment rate).

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Kandel, MD

CONTACT

[email protected]

14164696252

Sponsors and collaborators

Lead sponsor

Michael Garron Hospital

Other

Collaborators

  • Ottawa Hospital Research Institute
  • University Health Network, Toronto

Registry information

Official study title

Oral Beta-lactams Versus Non-beta-lactamS for Treatment of Lower Extremity Osteomyelitis

Acronym: OSTEO

Important dates

Study start
2026
Primary completion
2031
Study completion
2033
First posted
Dec 5, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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