NCT00772447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 9, 2015

Completed
Last Updated

March 9, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

October 9, 2008

Results QC Date

September 9, 2011

Last Update Submit

February 23, 2015

Conditions

Skin DiseasesInfectious

Keywords

Skin InfectionsComplicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens

Outcome Measures

Primary Outcomes (5)

  • 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

  • Change in Creatinine Clearance

    baseline to TOC(test of cure), for up to 4 weeks

  • Change in Serum Total Creatine Phosphokinase (CPK)

    baseline to TOC(test of cure), for up to 4 weeks

  • Change in Urine pH

    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

    baseline to TOC(test of cure), for up to 4 weeks

Secondary Outcomes (7)

  • Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)

    baseline and TOC, for up to 4 weeks

  • Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)

    baseline and EOT(end of therapy), for up to 2 weeks

  • Microbiological Response at TOC(Test of Cure)

    baseline and TOC, for up to 4 weeks

  • Microbiological Response at EOT(End of Therapy)

    baseline and EOT, for up to 2 weeks

  • Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)

    baseline and TOC, for up to 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

AZ drug

EXPERIMENTAL

Daptomycin

Drug: Daptomycin

Comparator

ACTIVE COMPARATOR

Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin

Drug: Vancomycin

Interventions

DaptomycinDRUG

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

Also known as: Cubicin®
AZ drug
VancomycinDRUG

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

Comparator

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Suzhou, Jiangsu, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Chongqing, China

Location

Research Site

Dalian, China

Location

Research Site

Hangzhou, China

Location

Research Site

Qingdao, China

Location

Related Links

MeSH Terms

Conditions

Skin DiseasesCommunicable DiseasesCellulitis

Interventions

DaptomycinVancomycin

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesInflammation

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsGlycopeptidesGlycoconjugatesCarbohydrates

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Karen Atkin

    AstraZeneca

    STUDY DIRECTOR

  • Zhang Yingyuan, Prof.

    Antibiotics Institute, Huashan Hospital Affilicated to Fudan University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 15, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

March 9, 2015

Results First Posted

March 9, 2015

Record last verified: 2015-02

Locations

CN(13)