Clinical trial NCT05584007: Cellulitis Optimal Antibiotic Treatment
Official title: A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cellulitis of Leg
Keywords: Primary care
Antibiotic treatment
Antibiotic resistance
Pain
Cost consequences
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University of East Anglia
name: University of Nottingham
name: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: University Hospital Southampton NHS Foundation Trust
First posted: 2022-10-18
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A phase III blinded, multi-center, non-inferiority trial assessing the effectiveness and safety of 5 days vs 7 days of oral flucloxacillin 500mg QDS for lower leg cellulitis, and to evaluate the cost-consequences of a shorter course from an NHS and personal perspective. Participants will be recruited in NHS primary care settings in England and Wales. We will primarily recruit through general practices but will explore the possibility of recruiting through out-of-the-hours and urgent care settings.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cellulitis is a deep infection of the skin and subcutaneous tissues and most often occurs in the legs. It is a painful condition that is associated with inflammation and swelling of the site, and often systemic symptoms such as fever, headache, muscle aches, malaise, and fatigue. Patients report feeling unwell and that it has a significant impact on their mobility and ability to carry out their usual activities. NICE guidelines recommend oral flucloxacillin 500-1000 mg four times daily for 5-7 days as first-line treatment for most patients with cellulitis in the community, but most prescriptions are dispensed for a 7-day course. We will be assessing the effectiveness and safety of a 5-day treatment vs. the standard 7-day treatment. We also aim to evaluate the cost-consequences of a shorter course from an NHS and personal perspective. Participants will be randomly allocated to one of two groups. In addition to usual care, participants will either be assigned to a 5-day oral flucloxacillin course or a standard 7-day flucloxacillin course. Participants will be prescribed a 5-day course of oral flucloxacillin, and two additional tablets will be posted to the participants which will either be the antibiotic or a placebo tablet. Participants will be asked to fill out daily questionnaires and express their experiences with the shortened course and taking part in the trial.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment
timeFrame: Days 7-16
Secondary outcomes:
measure: Use of additional antibiotics
timeFrame: Up to day 28
measure: Patient-reported assessment of how well they are feeling
timeFrame: Days 6-14
measure: Health related quality of life
timeFrame: Days 6-14
measure: Health related quality of life used to estimate Quality Adjusted- Life Years (QALYs)
timeFrame: Days 6-14
measure: Leg swelling and warmth
timeFrame: Day 7, 14, 21, 28
measure: Time until self-reported recovery
timeFrame: Day 7, 14, 21, 28
measure: Time until self-assessed extent of cellulitis starts to reduce (with no subsequent increase)
timeFrame: Day 7, 14, 21, 28
measure: Hospital admissions
timeFrame: 12 months
measure: Recurrent cellulitis episodes over 12 months (number of episodes)
timeFrame: 12 months
measure: Complications over 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Royal South Hants Hospital
Study officials:
References: