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

ConditionsOsteomyelitis of Lower Extremities Osteomyelitis - Foot Osteomyelitis of the Foot

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorMichael Garron Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior enrolment in the OSTEO trial

Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM

Allergy

Suspected or confirmed antimicrobial resistance

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

1,418 Participants

are divided into 2 treatment groups

Group A: Oral Beta-Lactam AntibioticExperimental treatment 1 intervention

Group B: Oral Non-Beta-Lactam AntibioticActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

24 Weeks

Secondary outcomes

Secondary Effectiveness Outcomes

The number of participant deaths.

Time frame

24 Weeks

Secondary Effectiveness Outcomes

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

Time frame

24 weeks

Secondary Effectiveness Outcome

Number and level of amputations

Time frame

24 weeks

Secondary Effectiveness Outcome

Number of debridement operations

Time frame

24 weeks

Other outcomes

Feasibility Outcome

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

Time frame

24 weeks

Feasibility Outcome

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

Time frame

24 weeks

Feasibility Outcome

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

Time frame

24 weeks

Sponsors and contacts

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Michael Garron Hospital

Lead sponsor

University Health Network, Toronto

Collaborator

Ottawa Hospital Research Institute

Collaborator

Source ClinicalTrials.gov

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