China Registration Study in Patients With Skin Infections

Skin Diseases Clinical Trial

Official title:

A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of 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 cSSSI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772447
• Other study ID #: D1790C00003
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2008
• Last updated: February 23, 2015
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: February 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Provision of inform consent

• A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria

• Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing

Exclusion Criteria:

• Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study

• Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,

• Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)

• Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infectious
• Skin Diseases

Intervention

Drug:
• Daptomycin
4mg/kg IV ; Q 24 hr (once every 24 hours)
• Vancomycin
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

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changsha	Hunan
China	Research Site	Chengdu	Sichuan
China	Research Site	Chongqing
China	Research Site	Dalian
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou
China	Research Site	Nanjing	Jiangsu
China	Research Site	Qingdao
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Suzhou	Jiangsu
China	Research Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline to TOC(test of cure), for up to 4 weeks	No
Primary	Change in Creatinine Clearance		baseline to TOC(test of cure), for up to 4 weeks	No
Primary	Change in Serum Total Creatine Phosphokinase (CPK)		baseline to TOC(test of cure), for up to 4 weeks	No
Primary	Change in Urine pH		baseline to TOC(test of cure), for up to 4 weeks	No
Primary	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	baseline to TOC(test of cure), for up to 4 weeks	No
Secondary	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)	baseline and TOC, for up to 4 weeks	No
Secondary	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)	baseline and EOT(end of therapy), for up to 2 weeks	No
Secondary	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.	baseline and TOC, for up to 4 weeks	No
Secondary	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.	baseline and EOT, for up to 2 weeks	No
Secondary	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.	baseline and TOC, for up to 4 weeks	No
Secondary	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.	baseline and TOC(test of cure), for up to 4 weeks	No
Secondary	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.	baseline and TOC(test of cure), for up to 4 weeks	No

External Links

•   Link
•   CSR-D1790C00003.pdf