The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
265
4mg/kg IV ; Q 24 hr (once every 24 hours)
Vancomycin - 1g per 12 hrs, for 7-14 days Or switch to Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin: \- 1 g every 6 hours or 2 g every 8 hours
Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Wuhan, Hubei, China
Research Site
Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Change in Creatinine Clearance
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Change in Serum Total Creatine Phosphokinase (CPK)
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Change in Urine pH
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Shift in ECG
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
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
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)
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Changsha, Hunan, China
Research Site
Nanjing, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
Research Site
Shenyang, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Chengdu, Sichuan, China
Research Site
Chongqing, China
...and 3 more locations
Time frame: baseline and TOC, for up to 4 weeks
Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)
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)
Time frame: baseline and EOT(end of therapy), for up to 2 weeks
Microbiological Response at TOC(Test of Cure)
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.
Time frame: baseline and TOC, for up to 4 weeks
Microbiological Response at EOT(End of Therapy)
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.
Time frame: baseline and EOT, for up to 2 weeks
Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)
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.
Time frame: baseline and TOC, for up to 4 weeks
Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC
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.
Time frame: baseline and TOC(test of cure), for up to 4 weeks
Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC
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.
Time frame: baseline and TOC(test of cure), for up to 4 weeks