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Can shorter antibiotic courses prevent infections in Kids' broken bones?

NCT ID NCT06055712

Disease control Sponsor: St. Louis University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at 800 children with mild open fractures to see how much antibiotic is needed to prevent infections. Some kids get one dose, some get 24 hours, and some get 24 hours plus five days of pills. The goal is to find the best balance between preventing infection and avoiding unnecessary antibiotics.

What this could mean

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

Active substance
Cefazolin and cephalexin (antibiotics)
What this could lead to
If successful, this could identify the shortest effective antibiotic course to prevent infections in children with mild open fractures, reducing unnecessary antibiotic use.
What could go wrong
This is a phase 4 study, so the drugs are already approved, but the optimal duration is unknown. The results may not apply to more severe fractures or older patients.

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 800 people

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

Started

Sep 2023

Expected to finish

Jan 2034

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

0 to 17 years

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: * Pediatric patients ages 0-17 years old * Skeletally immature patients, as confirmed by xray imaging evaluated by an orthopaedic surgeon * Patient as sustained a grade 1 or 2 open fracture within 24 hours of presentation * Physician plans to manage the fracture non-operatively Exclusion Criteria: * Patients 18 years or older * Skeletally mature patients, as as confirmed by xray imaging evaluated by an orthopaedic surgeon * Patients with grade 3 open fractures * Gross contamination of the fracture * Fracture requires surgery * Immunocompromised patients * Allergies to cephalosporins * Severe penicillin allergy * non-English speaking patients \&/or guardian

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Open Infections infectious disease prevention target

As listed by the trial registrant

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

Fractures, open Infections

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Saint Louis University

    St Louis, Missouri, 63110, United States

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