China Registration Study in Patients With Skin Infections
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Diseases; Infectious
Intervention: Daptomycin (Drug); Vancomycin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Karen Atkin, Study Director, Affiliation: AstraZeneca
Zhang Yingyuan, Prof., Principal Investigator, Affiliation: Antibiotics Institute, Huashan Hospital Affilicated to Fudan University
Summary
The objectives of this study is to evaluate the Safety and Efficacy of Intravenous
Daptomycin (CubicinŽ)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.
Clinical Details
Official title: A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of the Safety and Efficacy of Intravenous Daptomycin (CubicinŽ)Compared With That of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects With cSSSI
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)Change in Creatinine Clearance Change in Serum Total Creatine Phosphokinase (CPK) Change in Urine pH Shift in ECG
Secondary outcome: Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy) Microbiological Response at TOC(Test of Cure) Microbiological Response at EOT(End of Therapy) Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure) Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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)
Locations and Contacts
Research Site, Chongqing, China
Research Site, Dalian, China
Research Site, Hangzhou, China
Research Site, Qingdao, China
Research Site, Beijing, Beijing, China
Research Site, Guangzhou, Guangdong, China
Research Site, Wuhan, Hubei, China
Research Site, Changsha, Hunan, China
Research Site, Nanjing, Jiangsu, China
Research Site, Suzhou, Jiangsu, China
Research Site, Shenyang, Liaoning, China
Research Site, Shanghai, Shanghai, China
Research Site, Chengdu, Sichuan, China
Additional Information
CSR-D1790C00003.pdf
Starting date: September 2008
Last updated: February 23, 2015
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