A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
United Kingdom
Royal South Hants Hospital
RECRUITING
Southampton
Contact Information
Primary
Sophie Varkonyi-Clifford
coat@soton.ac.uk
0 23 8059 1532
Backup
Ella Bourke
coat@soton.ac.uk
02381550206
Time Frame
Start Date: 2023-08-29
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 356
Treatments
Placebo_comparator: Intervention
Flucloxacillin 500mg four times a day (QDS) for 5 days (unblinded NHS prescription) followed by blinded placebo QDS for 2 days (5 days of antibiotic)
Active_comparator: Control
Flucloxacillin 500mg QDS for 5 days (unblinded NHS prescription) followed by flucloxacillin 500mg QDS (blinded) for 2 days (7 days of antibiotic)
Related Therapeutic Areas
Sponsors
Leads: University of Southampton
Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust, University of Nottingham, University Hospital Southampton NHS Foundation Trust, University of East Anglia