China Registration Study in Patients With Skin Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00772447
First received: October 9, 2008
Last updated: February 23, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Skin Diseases
Infectious
Drug: Daptomycin
Drug: Vancomycin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood) [ Time Frame: baseline to TOC(test of cure), for up to 4 weeks ] [ Designated as safety issue: No ]
    Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood

  • Change in Creatinine Clearance [ Time Frame: baseline to TOC(test of cure), for up to 4 weeks ] [ Designated as safety issue: No ]
  • Change in Serum Total Creatine Phosphokinase (CPK) [ Time Frame: baseline to TOC(test of cure), for up to 4 weeks ] [ Designated as safety issue: No ]
  • Change in Urine pH [ Time Frame: baseline to TOC(test of cure), for up to 4 weeks ] [ Designated as safety issue: No ]
  • Shift in ECG [ Time Frame: baseline to TOC(test of cure), for up to 4 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure) [ Time Frame: baseline and TOC, for up to 4 weeks ] [ Designated as safety issue: No ]
    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)

  • Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy) [ Time Frame: baseline and EOT(end of therapy), for up to 2 weeks ] [ Designated as safety issue: No ]
    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)

  • Microbiological Response at TOC(Test of Cure) [ Time Frame: baseline and TOC, for up to 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Microbiological Response at EOT(End of Therapy) [ Time Frame: baseline and EOT, for up to 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure) [ Time Frame: baseline and TOC, for up to 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC [ Time Frame: baseline and TOC(test of cure), for up to 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC [ Time Frame: baseline and TOC(test of cure), for up to 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 265
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZ drug
Daptomycin
Drug: Daptomycin
4mg/kg IV ; Q 24 hr (once every 24 hours)
Other Name: Cubicin®
Active Comparator: Comparator
Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin
Drug: 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


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772447

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China
Research Site
Chongqing, China
Research Site
Dalian, China
Research Site
Hangzhou, China
Research Site
Qingdao, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Karen Atkin AstraZeneca
Principal Investigator: Zhang Yingyuan, Prof. Antibiotics Institute, Huashan Hospital Affilicated to Fudan University
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00772447     History of Changes
Other Study ID Numbers: D1790C00003
Study First Received: October 9, 2008
Results First Received: September 9, 2011
Last Updated: February 23, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Skin Infections
Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens

Additional relevant MeSH terms:
Skin Diseases
Cloxacillin
Daptomycin
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015