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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2033-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteomyelitis of Lower Extremities Osteomyelitis - Foot Osteomyelitis of the Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Beta-Lactam Antibiotic

Group Type EXPERIMENTAL

Oral Beta-Lactam Antibiotic

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Oral Non-Beta-Lactam Antibiotic

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No