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Could a shorter antibiotic course be just as good for leg infections?

NCT ID NCT05584007

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares a 5-day course of the antibiotic flucloxacillin to the standard 7-day course for adults with leg cellulitis. About 334 participants will receive either 5 days of active drug plus 2 days of placebo, or 7 days of active drug. The goal is to see if the shorter course is non-inferior in controlling pain and preventing recurrence, which could lead to less antibiotic use and fewer side effects.

What this could mean

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

Active substance
flucloxacillin
What this could lead to
If successful, this could show that a shorter course of antibiotics is just as effective, reducing side effects and antibiotic resistance.
What could go wrong
This is a non-inferiority trial, so it may find that 5 days is slightly less effective. Results may not apply to severe cases or people with allergies.

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 334 people

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

Started

Aug 2023

Expected to finish

Jul 2027

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: * Must be aged 18 years or older * Currently showing symptoms of cellulitis (such as pain, tenderness, redness, other change in skin color, warmth to touch) in one leg for 10 days or less * Pain rated as 3/10 or higher on a numerical rating scale (0-10) at baseline assessment * Be willing to be randomized to either trial arm (5-day or 7-day treatment) * Able to complete trial procedures in the English language. Exclusion Criteria: * Have penicillin allergy * Have bilateral cellulitis * Have had antibiotics for cellulitis within the past month * Have post-operative cellulitis (within 30 days of operative procedures on the same leg) * Have cellulitis resulting from human/animal bite injury * Have Cellulitis associated with chronic (\>6 weeks) leg ulceration * Require immediate hospital admission or out-patient intravenous antibiotic therapy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    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

  • Royal South Hants Hospital

    RECRUITING

    Southampton, United Kingdom

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