None listed
Conditions
Brief summary
Cellulitis and erysipelas are common skin infections, and it is not known what the ideal duration of IV therapy is for treatment. This is a trial which commenced at Barwon Health in November 2012 expanded to multiple sites in Australia and New Zealand to study whether a short-course of IV therapy is not inferior to longer duration IV therapy. Over 300 participants are required for this trial, however a lack of funding led to only 80 being recruited. The trial was ceased in 2016. Patients who attend hospital emergency departments, or are admitted to hospital wards, or hospital in the home (HITH) programs with a diagnosis of cellulitis and are planned for IV therapy are reviewed to determine if they fulfill the criteria for inclusion in the trial. Those who meet the criteria and agree to participate are consented to participation in the trial, and are then randomly allocated to either IV therapy of 72 hours or more (as an inpatient or on hospital in the home) or 24 hours IV therapy, both followed by oral therapy for a maximum of 7-10 days. Antibiotics that are used are those ordinarily recommended for cellulitis and are not experimental. Each participant is involved for approximately one month, including 3 visits over the first 10 days and a follow-up phone contact at Day 30. In order to determine that short course IV therapy is safe and effective when compared to longer durations, we measure the following things to determine that cellulitis has resolved: 1) That fever has resolved at 48-72 hours 2) That skin abnormalities have not gotten worse at Days 7-10 3) That ongoing antibiotic therapy is not required after 10 days. We also measure; time taken for fever to resolve, pain as reported by the patient, photos of the affected leg over the first 10 days, and whether there are any side effects that patients experience while on this trial. At 30 days the patient is telephoned to check that their cellulitis has not recurred.
Interventions
24 hours intravenous antibiotic therapy followed by oral antibiotics to a maximum of 7-10 days.
Intravenous antibiotics: We recommend flucloxacillin 2 grams given over 20-30 minutes every 6 hours, or cephazolin 2 grams given over 20-30 minutes 2-3 times daily (2-3 times daily if given at home, or 3 times daily if given in the hospital). Any antibiotic with activity against Steptococcus and Staphylococcus spp. is however allowable. The antibiotic used may differ according to patient allergies, b
24 hours intravenous antibiotic therapy followed by oral antibiotics to a maximum of 7-10 days. Intravenous antibiotics: We recommend flucloxacillin 2 grams given over 20-30 minutes every 6 hours, or cephazolin 2 grams given over 20-30 minutes 2-3 times daily (2-3 times daily if given at home, or 3 times daily if given in the hospital). Any antibiotic with activity against Steptococcus and Staphylococcus spp. is however allowable. The antibiotic used may differ according to patient allergies, but not physician discretion. Following 24 hours of intravenous therapy patients are switched to oral antibiotics for 6-9 days. Total duration of antibiotics is 7-10 days. Oral antibiotics: flucloxacillin 500 mg 4 times daily or cephalexin 500 mg 4 times daily. These medicines are administered by the patient, but are approximately at 6 hour intervals. Any antibiotic with activity against Steptococcus and Staphylococcus spp. is however allowable depending on patient allergies. Adherence to oral treatment is determined by drug tablets remaining at study visits at days 2-3 and 7-10.
Sponsors
Barwon Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute cellulitis of lower limb with consistent clinical features, including; erythema, pain, and swelling with onset within 5 days with either fever on clinical examination or history consistent with fevers and/or chills, rigors, nausea within 5 days prior to presentation 2. Age > 18 years 3. Patient is planned for intravenous antibiotics via hospital admission or hospital-in-the-home treatment for cellulitis of the lower limb
Exclusion criteria
1. Age <18 years 2. Pregnant female 3. Immunosuppression including any one of: active chemotherapy in the last 6 weeks, receipt of prednisolone >20mg/ day, or neutropaenia with neutrophil count <0.5 x 109/L or alternative conditions significantly affecting the immune system 4. Alternative diagnosis, including but not limited to: venous eczema, Diabetic foot infection, Surgical site (wound) infection or other open wound 5. Penetrating injury or bite 6. Suspected complication such as abscess or necrotising infection 7. Septic shock or other reasons for intensive care unit admission 8. Oral antibiotics effective against cellulitis for > 48 hours or IV antibiotics effective against cellulitis for >24 hours. (including receipt of flucloxacillin, dicloxacillin, cephalexin, cephazolin, clindamycin and Vancomycin). 9. Patient unwilling to participate or in the opinion of investigators will be unable to comply with the requirements of the study.
Outcome results
None listed