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Pill power: could oral antibiotics replace IV drips for infected fractures?

NCT ID NCT05699174

Disease control Sponsor: Major Extremity Trauma Research Consortium 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study compares oral (pill) antibiotics to intravenous (IV) antibiotics for treating infected broken bones that haven't healed properly. About 250 adults with this condition will be randomly assigned to receive either oral or IV antibiotics for up to 6 weeks after surgery. The goal is to see if the pills work just as well as the IV treatment, which could make treatment easier and less invasive.

What this could mean

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

Active substance
antibiotics (oral or intravenous)
What this could lead to
If oral antibiotics prove as effective as IV, patients could avoid hospital stays and IV lines, making treatment easier and cheaper.
What could go wrong
This is a phase 3 trial, but results may not apply to all infections or patients. Oral antibiotics might be less effective for severe cases, and infection recurrence is possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

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

Started

May 2023

Expected to finish

Sep 2028

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. 1\. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible. 2. Infection as determined by either 1. FRI criteria 2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon 3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks Exclusion Criteria: 1. Patients with a high risk of amputation based on the initial managing physician 2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment 3. Incarcerated or institutionalized patients 4. Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic 5. Patients with a prior history of chronic infection at the index site before fracture fixation 6. Patients with pathological fractures from a neoplastic process 7. History of Paget's Disease 8. The patient, or a designated proxy, unwilling to provide consent 9. The patient must be available for follow-up for at least 12 months following infection treatment

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Ununited Infections infectious disease Inflammation Leg Injuries Wound Infection

As listed by the trial registrant

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

Amputation Antibiotic side effect Fracture Infected wound Infections Injury leg Internal fixation; complications, infection or inflammation Lower extremity fracture Nonunion of fracture

How to take part

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

  1. The places running it

    13 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

  • Atrium Health, Carolinas Medical Center

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Hennepin Health

    RECRUITING

    Minneapolis, Minnesota, 55487, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Jamaica Hospital Medical Center

    NOT_YET_RECRUITING

    Queens, New York, 11418, United States

  • Penn State University M.S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Sinai Hospital Baltimore

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21215, United States

  • University of Maryland , MD Department of Orthopaedics

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Okalahoma College of Medicine

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Washington Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Vanderbilt Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Wake Forest University Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.