cellulitis erysipelas skin infection
Conditions
Interventions
12 days of antibiotic therapy (i.e. flucloxacilline) or 6 days of antibiotic
therapy, followed by 6 days of placebo.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years of age or older - Admitted to the hospital for skin infection (cellulitis) - Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form - Not participating in another clinical therapeutic trial on antibiotics;Healthy volunteers: - 18 years and older
Exclusion criteria
Exclusion criteria: - Allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders. - Concurrent use of antibiotics for other indications - Alternative diagnosis accounting for the clinical presentation. - All cases involving complicating factors (see protocol);Healthy volunteers: - No abscess, cellulitis, dermatitis or psoriasis in/on the leg in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is resolution of cellulitis at 14 days after study enrolment, and without recurrence by day 28 (defined as the need for additional antibiotics for cellulitis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are length of hospital stay, health-related quality of life, total antibiotic use and effect on direct and indirect health-care associated costs. | — |
Countries
Netherlands
Outcome results
None listed