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Can common penicillins beat stronger antibiotics for bone infections?

NCT ID NCT07266753

Disease control Sponsor: Michael Garron Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether two different classes of oral antibiotics—beta-lactams (like penicillins) and non-beta-lactams (like fluoroquinolones)—work equally well for treating bone infections in the leg or foot. About 1,400 adults with lower extremity osteomyelitis will be randomly assigned to one of the two antibiotic groups. The goal is to see if the simpler, often cheaper beta-lactam antibiotics are just as effective at curing the infection without needing surgery or switching drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral antibiotics (beta-lactam and non-beta-lactam classes)
What this could lead to
If successful, this trial could show that oral beta-lactam antibiotics are as effective as non-beta-lactams for treating bone infections, offering more treatment options.
What could go wrong
This is a feasibility study first, so it may not provide a definitive answer. The results may not apply to all patients or infection types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,418 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

osteomyelitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteomyelitis - foot Osteomyelitis of lower extremities Osteomyelitis of the foot

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Michael Garron Hospital

    RECRUITING

    Toronto, Ontario, M4C 3E7, Canada

  • Ottawa Hospital

    NOT_YET_RECRUITING

    Ottawa, Ontario, K1Y 4E9, Canada

  • University Health Network

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

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