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| |  Moxifloxacin Effective, Safe for Treatment of Patients With Complicated Skin, Skin Structure Infection: Presented at ECCMID By Chris Berrie HELSINKI, Finland -- May 26, 2009 -- Moxifloxacin (MXF) is well tolerated and noninferior to piperacillin/tazobactam followed by amoxicillin-clavulanic acid (PIP/TAZ-AMC) for treatment of patients with complicated skin and skin structure infection (cSSSI), according to a study presented here at the 19th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Complicated SSSIs are often polymicrobial and require broad-spectrum antibiotic treatment, and the search for optimal empiric antimicrobial treatment continues. Principal investigator Inge C. Gyssens, MD, Infectious Diseases, Radboud University Medical Centre, and Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands, presented the results of a multicentre, prospective, randomised, double-dummy, double-blind study on May 18. Researchers compared the safety and efficacy of 2 sequential both intravenous (IV) and oral (PO) application treatments across 4 specific cSSSIs: major abscess, diabetic foot infection (DFI), wound infection, and infected ischaemic ulcer (IIU), stratified according to severity and need for surgery. Inclusion criteria were for adults aged 18 years and older with bacterial cSSSI of less than 21 days that required hospitalisation and initial parenteral treatment for 48 hours or more. Involvement of deep soft tissues, significant surgical intervention, and association with a significant underlying disease were also specified. Patients were stratified according to cSSSI diagnosis, infection severity, and requirement for surgery. Study treatments were for 21 days with sequential IV/PO MXF 400 mg QD or IV PIP/TAZ 4.0/0.5 g TID followed by AMC PO 875/125 mg BID. Patients were randomised to the sequence order of active and placebo IV drug, and the switch from IV to PO therapy was at the physician's discretion, according to patient response. The primary efficacy endpoint was clinical response at test of cure (TOC; 14-28 days after end of treatment [EOT]), with the main analysis based on the per protocol (PP) population. Secondary efficacy variables included clinical and bacteriological responses on days 3-5, and at EOT and TOC. A total of 813 patients were randomised to MXF (PP: n = 363; mean age, 52.7 years; male, 63.4%) or PIP/TAZ-AMC (PP: n = 307: mean age, 51.8 years; male, 69.4%). Baseline clinical characteristics were similar across the treatments, including patient temperatures >38 degrees Celsius and Wilson score risk class, and infection type, cSSSI diagnosis, and primary lesion location. For the overall clinical response rates, as Dr. Gyssens said, "The main result is that [moxifloxacin] is noninferior." These response rates were thus similar across the 2 treatment groups: 88.7% versus 89.6%, respectively. According to diagnosis, clinical responses were consistent across the treatments, as PP: major abscess, 95.8% versus 96.1%; DFI, 76.6% versus 78.1%; wound infection, 95.2% versus 95.7%; and IIU, 77.3% versus 72.5%. Similarly, but with decreasing effectiveness, response rates across the Wilson risk scores were 96.0% versus 100.0% for major abscess; 91.7% versus 94.4% for DFI: 90.9% versus 84.9% for wound infection; and 77.5% versus 77.8% for IIU. Both treatments also showed good bacteriological efficacy, with overall response rates of 84.4% versus 87.2%, respectively. Again, this showed the noninferiority of MFX and PIP/TAZ-AMC. In the intention-to-treat safety population, incidents of drug-related, treatment-emergent adverse events were also similar according to treatment (8.6% vs 7.3%), with the most frequent being diarrhoea and hypertension. Although there were 4 deaths during the study, none was considered to be study-drug related.
[Presentation titles: Efficacy of IV/Oral Moxifloxacin in the Treatment of Complicated Skin and Skin-Structure Infections: Results of the RELIEF Study. Abstract P1785;
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