- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00772447
China Registration Study in Patients With Skin Infections
February 23, 2015 updated by: AstraZeneca
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
265
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chongqing, China
- Research site
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Dalian, China
- Research site
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Hangzhou, China
- Research site
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Qingdao, China
- Research site
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Beijing
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Beijing, Beijing, China
- Research site
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Guangdong
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Guangzhou, Guangdong, China
- Research site
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Hubei
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Wuhan, Hubei, China
- Research site
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Hunan
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Changsha, Hunan, China
- Research site
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Jiangsu
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Nanjing, Jiangsu, China
- Research site
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Suzhou, Jiangsu, China
- Research site
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Liaoning
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Shenyang, Liaoning, China
- Research site
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Shanghai
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Shanghai, Shanghai, China
- Research site
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Sichuan
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Chengdu, Sichuan, China
- Research site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AZ drug
Daptomycin
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4mg/kg IV ; Q 24 hr (once every 24 hours)
Other Names:
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Active Comparator: Comparator
Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood
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baseline to TOC(test of cure), for up to 4 weeks
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Change in Creatinine Clearance
Time Frame: baseline to TOC(test of cure), for up to 4 weeks
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baseline to TOC(test of cure), for up to 4 weeks
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Change in Serum Total Creatine Phosphokinase (CPK)
Time Frame: baseline to TOC(test of cure), for up to 4 weeks
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baseline to TOC(test of cure), for up to 4 weeks
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Change in Urine pH
Time Frame: baseline to TOC(test of cure), for up to 4 weeks
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baseline to TOC(test of cure), for up to 4 weeks
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Shift in ECG
Time Frame: baseline to TOC(test of cure), for up to 4 weeks
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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
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baseline to TOC(test of cure), for up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
Time Frame: baseline and TOC, for up to 4 weeks
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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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baseline and TOC, for up to 4 weeks
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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
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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)
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baseline and EOT(end of therapy), for up to 2 weeks
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Microbiological Response at TOC(Test of Cure)
Time Frame: baseline and TOC, for up to 4 weeks
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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.
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baseline and TOC, for up to 4 weeks
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Microbiological Response at EOT(End of Therapy)
Time Frame: baseline and EOT, for up to 2 weeks
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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.
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baseline and EOT, for up to 2 weeks
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Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)
Time Frame: baseline and TOC, for up to 4 weeks
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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.
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baseline and TOC, for up to 4 weeks
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Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC
Time Frame: baseline and TOC(test of cure), for up to 4 weeks
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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.
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baseline and TOC(test of cure), for up to 4 weeks
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Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC
Time Frame: baseline and TOC(test of cure), for up to 4 weeks
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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.
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baseline and TOC(test of cure), for up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Karen Atkin, AstraZeneca
- Principal Investigator: Zhang Yingyuan, Prof., Antibiotics Institute, Huashan Hospital Affilicated to Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
October 9, 2008
First Submitted That Met QC Criteria
October 14, 2008
First Posted (Estimate)
October 15, 2008
Study Record Updates
Last Update Posted (Estimate)
March 9, 2015
Last Update Submitted That Met QC Criteria
February 23, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1790C00003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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