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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
356
Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by blinded flucloxacillin 500mg for 2 days, reaching a total of 7 days of antibiotic treatment
Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by a blinded placebo for 2 days, reaching a total of 5 days of antibiotic treatment
Royal South Hants Hospital
Southampton, United Kingdom
RECRUITINGPain assessment
Self-reported pain (measured using the Pain Numeric Rating Scale (0-10))
Time frame: Days 7-16
Use of additional antibiotics
Any reported use of antibiotics other than the initial 5 days of flucloxacillin and 2 days of IMP)
Time frame: Up to day 28
Patient-reported assessment of how well they are feeling
Numeric rating scale NRS (0-10) and assessed as repeated measures
Time frame: Days 6-14
Health related quality of life
EQ-5D-5L - values, and individual dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) level scores using repeated measures.
Time frame: Days 6-14
Health related quality of life used to estimate Quality Adjusted- Life Years (QALYs)
EQ-5D-5L - values, and individual dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) level scores using repeated measures.
Time frame: Days 6-14
Leg swelling and warmth
Participant reported questionnaire
Time frame: Day 7, 14, 21, 28
Time until self-reported recovery
Participant reported questionnaire
Time frame: Day 7, 14, 21, 28
Time until self-assessed extent of cellulitis starts to reduce (with no subsequent increase)
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Participant reported questionnaire
Time frame: Day 7, 14, 21, 28
Hospital admissions
Number of hosptial admissions since randomisation, collected from primary care notes review
Time frame: 12 months
Recurrent cellulitis episodes over 12 months (number of episodes)
Recurrent cellulitis episodes over 12 months (number of episodes) since randomisation, collected from primary care notes review
Time frame: 12 months
Complications over 12 months
Number of reported complications since randomisation, collected from primary care notes review
Time frame: 12 months