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Antibiotic study for broken legs canceled before it began

NCT ID NCT05267977

Knowledge-focused Sponsor: Methodist Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 aimed to find out if adding a strong antibiotic (aminoglycoside) to a standard one (cephalosporin) helps people with open leg fractures. It was planned for adults with severe open fractures, but the study was withdrawn and no one took part. No results are available.

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.

Started

Aug 2016

Finished

May 2022

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: * Male and female patients ≥ 18 years of age * All patients with open grade II or grade III lower extremity open fractures according to the Gustilo Classification of open fracture. Exclusion Criteria: * Any significant injuries in addition to the lower extremity fracture as determined by the PI that may confound the data. * Inability to give informed consent or comply with data acquisition (Part 3). * Pregnant or breast feeding patients due to the potential risks to the mother and/or fetus. * Prisoners * Previous bone malignancy * Bowel or enteric injury at index admission * TBI of AIS ≥ 5

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As listed by the trial registrant

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

Lower extremity fracture

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