Cellulitis
Conditions
Keywords
Clindamycin, Cellulitis, Flucloxacillin, Group A streptococcus, Staphylococcus aureus
Brief summary
The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin, results in less tissue damage and a more rapid resolution of both systemic and local features, in a cost-effective manner. This study is a randomised controlled trial comparing Clindamycin with placebo.
Detailed description
Criteria to be used to assess tissue damage and clinical response: 1. Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin 2. Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected) 3. Document the duration between initial systemic features and the development of local signs 4. Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis 5. Examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis 6. Identify and quantify possible side effects of clindamycin
Interventions
DRUGFlucloxacillin
Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
DRUGClindamycin
Clindamycin dose 300mg four times each day for 2 days, within 48 hours of commencing flucloxacillin. Clindamycin is over-encapsulated and externally identical to placebo.
DRUGPlacebo oral capsule
Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days
Sponsors
University of Bristol
Public Health England
University Hospitals Bristol and Weston NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb * Who are able to understand the study and give consent * Who are able to take oral medication
Exclusion criteria
* Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy * Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year * Patients unable to take oral medication * Previous history of Clostridium difficile colitis * Clindamycin taken within the last 30 days * Clinically unstable * Unable to understand the study or give consent * Any doubt over the certainty of the diagnosis of cellulitis * Patients taking any drug that is incompatible with either flucloxacillin or clindamycin * Pre-existing diarrhoea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement based on a composite of systemic and local features | Day 5 | Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in pain | Day 10 | Assessed using a visual analogue score |
| Quality of life | Day 30 | Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects. |
| Physiological recovery | Day 10 | Resolution of systemic features, composite inflammatory markers and recovery of renal function. |
Countries
United Kingdom
Outcome results
None listed