Health TrialsbyHealthPanel

Cellulitis Optimal Antibiotic Treatment

ConditionCellulitis of Leg
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southampton

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Flucloxacillin Only Product in Oral Dose Form

    Drug

    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

    Drug

    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

Treatment groups

334 Participants
are divided into 2 treatment groups
Group A: InterventionPlacebo comparator 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain assessment

Self-reported pain (measured using the Pain Numeric Rating Scale (0-10))

Time frame
Days 7-16

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southampton

Lead sponsor

University of East Anglia

Collaborator

University of Nottingham

Collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborator

University Hospital Southampton NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov
Apply now