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Recruiting NCT07266753

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

Phase IV Interventional Osteomyelitis of Lower Extremities Osteomyelitis - Foot Osteomyelitis of the Foot

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Beta-Lactam Antibiotic, Oral Non-Beta-Lactam Antibiotic.
Who it may be relevant to
Registry conditions: Osteomyelitis of Lower Extremities, Osteomyelitis - Foot, Osteomyelitis of the Foot. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug 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.
  • Drug 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 measures

  • Primary Effectiveness Outcomes [Time frame: 24 Weeks]
Secondary outcome measures (10)
  • Secondary Effectiveness Outcomes [Time frame: 24 Weeks]
  • Secondary Effectiveness Outcomes [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 24 weeks]
  • Secondary Effectiveness Outcome [Time frame: 52 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • Ottawa Hospital — Ottawa
  • Michael Garron Hospital — Toronto
  • University Health Network — Toronto

Identifiers

NCT: NCT07266753 · IDRU-INT-2024-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗