China Registration Study in Patients With Skin Infections

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Daptomycin

Vancomycin

About this trial

This is an interventional treatment trial for Skin Diseases focused on measuring Skin Infections, Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AZ drug

Comparator

Arm Description

Daptomycin

Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin

Outcomes

Primary Outcome Measures

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

Change in Creatinine Clearance

Change in Serum Total Creatine Phosphokinase (CPK)

Change in Urine pH

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

Secondary Outcome Measures

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)

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)

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT00772447

First Posted

October 9, 2008

Last Updated

February 23, 2015

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00772447

Brief Title

China Registration Study in Patients With Skin Infections

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Diseases, Infectious

Keywords

Skin Infections, Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AZ drug

Arm Type

Experimental

Arm Description

Daptomycin

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin

Intervention Type

Drug

Intervention Name(s)

Daptomycin

Other Intervention Name(s)

Cubicin®

Intervention Description

4mg/kg IV ; Q 24 hr (once every 24 hours)

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)

Description

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

Time Frame