Moxifloxacin in complicated skin and skin structure infections (cSSSIs): A prospective, international, non-interventional, observational study.

ABSTRACT

INTRODUCTION: ARTOS was an international, prospective, non-interventional, non-controlled observational study designed to determine the effectiveness, safety, and tolerability of moxifloxacin under daily-life conditions in patients with complicated skin and skin structure infections (cSSSIs) treated in Europe, the Middle East, and Asia-Pacific region. METHODS: Eligible patients included males and females who were hospitalized patients or outpatients requiring antibiotic therapy for cSSSIs and for whom the treating physician had elected to begin moxifloxacin therapy in accordance with its approved indications. Patients were assessed before therapy and then at one or two follow-up visits. Effectiveness was assessed with respect to improvement and resolution of signs and symptoms of cSSSIs and safety with respect to the nature and frequency of adverse events and adverse drug reactions. RESULTS: A total of 6,594 patients were enrolled of whom 5,444 had data available for analysis; 4,692 patients received sequential intravenous/oral (IV/PO) moxifloxacin and 752 exclusively IV therapy. A majority of patients were aged between 40 and 79 years and had one or more comorbid conditions. Post-surgical wound infection, skin abscess, and diabetic foot infection were the cSSSIs most frequently diagnosed and treated with moxifloxacin, with almost 90% of infections rated moderate or severe. Treating physicians chose sequential moxifloxacin 400 mg for most patients, switching from IV to PO after 3-4 days. On average, treatment was maintained for 10 days. Treatment with moxifloxacin was associated with rapid relief in symptoms, with 93.2% of patients experiencing either complete resolution of symptoms or improvement at follow-up. Moxifloxacin was well tolerated with adverse drug reactions occurring in only 2% of patients. CONCLUSIONS: This study, conducted in a 'real-world' setting, confirms the effectiveness and safety of moxifloxacin in the treatment of a wide spectrum of cSSSIs seen in routine clinical practice.