Royal South Hants Hospital
Southampton, United Kingdom
Location status: Recruiting
Location contact
Ian Ward
CONTACT
Ian Ward
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05584007
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Southampton, United Kingdom
Location status: Recruiting
Ian Ward
CONTACT
Ian Ward
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Days 7-16
Self-reported pain (measured using the Pain Numeric Rating Scale (0-10))
Time frame: Up to day 28
Any reported use of antibiotics other than the initial 5 days of flucloxacillin and 2 days of IMP)
Time frame: Days 6-14
Numeric rating scale NRS (0-10) and assessed as repeated measures
Time frame: Days 6-14
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
EQ-5D-5L - values, and individual dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) level scores using repeated measures.
Time frame: Day 7, 14, 21, 28
Participant reported questionnaire
Time frame: Day 7, 14, 21, 28
Participant reported questionnaire
Time frame: Day 7, 14, 21, 28
Participant reported questionnaire
Time frame: 12 months
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) since randomisation, collected from primary care notes review
Time frame: 12 months
Number of reported complications since randomisation, collected from primary care notes review
Contact information is provided by the study sponsor or research team.
Ella Bourke
CONTACT
Sophie Varkonyi-Clifford
CONTACT
University of Southampton
Other
A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis
Acronym: COAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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