Could a shorter antibiotic course be just as good for leg infections?
NCT ID NCT05584007
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 334 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Royal South Hants Hospital
RECRUITINGSouthampton, United Kingdom
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