Trial Outcomes & Findings for China Registration Study in Patients With Skin Infections (NCT NCT00772447)

Overall, 265 patients were randomised (daptomycin: 131 patients, comparator: 134 patients), with 264 patients receiving study treatment

China Registration Study in Patients With Skin Infections

Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood

percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline

The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days \[3 days for patients evaluated as treatment failure\]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC \[for systemicadministration of non-glycopeptides, \>1 calendar day\]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)

The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days \[3 days for patients evaluated as treatment failure\]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC \[for systemicadministration of non-glycopeptides, \>1 calendar day\]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)

The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.

The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.

This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.

This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.

This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.