Cellulitis Optimal Antibiotic Treatment
- Conditions
- Cellulitis of Leg
- Interventions
- Drug: Placebo Only Product in Oral Dose Form
- Registration Number
- NCT05584007
- Lead Sponsor
- University of Southampton
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 356
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Placebo Only Product in Oral Dose Form 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) Control Flucloxacillin Only Product in Oral Dose Form Flucloxacillin 500mg QDS for 5 days (unblinded NHS prescription) followed by flucloxacillin 500mg QDS (blinded) for 2 days (7 days of antibiotic) Intervention Flucloxacillin Only Product in Oral Dose Form 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)
- Primary Outcome Measures
Name Time Method Pain assessment Days 7-16 Self-reported pain (measured using the Pain Numeric Rating Scale (0-10))
- Secondary Outcome Measures
Name Time Method Health related quality of life used to estimate Quality Adjusted- Life Years (QALYs) Days 6-14 EQ-5D-5L - values, and individual dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) level scores using repeated measures.
Use of additional antibiotics Up to day 28 Any reported use of antibiotics other than the initial 5 days of flucloxacillin and 2 days of IMP)
Patient-reported assessment of how well they are feeling Days 6-14 Numeric rating scale NRS (0-10) and assessed as repeated measures
Health related quality of life Days 6-14 EQ-5D-5L - values, and individual dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) level scores using repeated measures.
Leg swelling and warmth Day 7, 14, 21, 28 Participant reported questionnaire
Time until self-reported recovery Day 7, 14, 21, 28 Participant reported questionnaire
Time until self-assessed extent of cellulitis starts to reduce (with no subsequent increase) Day 7, 14, 21, 28 Participant reported questionnaire
Hospital admissions 12 months Number of hosptial admissions since randomisation, collected from primary care notes review
Recurrent cellulitis episodes over 12 months (number of episodes) 12 months Recurrent cellulitis episodes over 12 months (number of episodes) since randomisation, collected from primary care notes review
Complications over 12 months 12 months Number of reported complications since randomisation, collected from primary care notes review
Trial Locations
- Locations (1)
Royal South Hants Hospital
🇬🇧Southampton, United Kingdom