A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria.

摘要: Summary Background:  Methicillin-susceptible and -resistant (MRSA) Staphylococcus aureus are significant causes of complicated skin structure infections (cSSSI). The bactericidal antibiotic daptomycin is approved for gram-positive cSSSI at 4 mg/kg/day 7–14 days, but the optimal dose level duration therapy have not been firmly established. This pilot study evaluated efficacy safety 10 mg/kg every 24 h 4 days [high-dose short (HDSD) regimen] vs. standard care with vancomycin or semi-synthetic penicillin treatment cSSSI. Methods:  was a semi-single blind, randomised, multicentre, comparative trial. primary end-point clinical response 7–14 days posttherapy. Results:  One hundred patients were randomised; 48 in each arm treated. groups well balanced respect to demographics, comorbidities type infection (75% because MRSA). Overall, success rates 75.0% (36/48) 87.5% (42/48) comparator (95% confidence interval difference: −27.9, 2.9). median 8 days. Two no experienced treatment-related serious adverse events requiring hospitalisation. Conclusion:  We found that HDSD regimen had profile similar seen previous studies. Although differences statistically significant, higher than daptomycin. In post hoc analyses performed better some subgroups (e.g. outpatients) others certain MRSA infections). These observations require confirmation larger trials.