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New treatment option for Osteomyelitis of Lower Extremities
Official title Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot
ClinicalTrials.gov ID: NCT07266753
What this study is testing
What is Oral Beta-Lactam Antibiotic?
Oral Beta-Lactam Antibiotic is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for osteomyelitis of lower extremities.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.