Cellulitis Optimal Antibiotic Treatment

Cellulitis of Leg Clinical Trial

— COAT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05584007
• Other study ID #: ERGO 67073
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 356
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cellulitis
• Cellulitis of Leg

Intervention

Drug:
• Flucloxacillin Only Product in Oral Dose Form
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
• Placebo Only Product in Oral Dose Form
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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Southampton	Norfolk and Norwich University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University of East Anglia, University of Nottingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	Self-reported pain (measured using the Pain Numeric Rating Scale (0-10))	Days 7-16
Secondary	Use of additional antibiotics	Any reported use of antibiotics other than the initial 5 days of flucloxacillin and 2 days of IMP)	Up to day 28
Secondary	Patient-reported assessment of how well they are feeling	Numeric rating scale NRS (0-10) and assessed as repeated measures	Days 6-14
Secondary	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.	Days 6-14
Secondary	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.	Days 6-14
Secondary	Leg swelling and warmth	Participant reported questionnaire	Day 7, 14, 21, 28
Secondary	Time until self-reported recovery	Participant reported questionnaire	Day 7, 14, 21, 28
Secondary	Time until self-assessed extent of cellulitis starts to reduce (with no subsequent increase)	Participant reported questionnaire	Day 7, 14, 21, 28
Secondary	Hospital admissions	Number of hosptial admissions since randomisation, collected from primary care notes review	12 months
Secondary	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	12 months
Secondary	Complications over 12 months	Number of reported complications since randomisation, collected from primary care notes review	12 months