Cellulitis Optimal Antibiotic Treatment
ConditionCellulitis of Leg
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southampton
About this trial
To determine whether a short course of oral flucloxacillin (5 days) is non-inferior to a standard course (7 days) in terms of pain over days 6-14 (indicative of persistence or recurrence associated with the symptoms of most importance to patients) in adults with cellulitis of the leg presenting in primary care.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Flucloxacillin Only Product in Oral Dose Form
- Placebo Only Product in Oral Dose Form
Treatment groups
334 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Southampton
Lead sponsor
University of East Anglia
Collaborator
University of Nottingham
Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
University Hospital Southampton NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov