Clinical trial NCT00772447: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Diseases
Infectious
Keywords: Skin Infections
Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
timeFrame: baseline to TOC(test of cure), for up to 4 weeks
measure: Change in Creatinine Clearance
timeFrame: baseline to TOC(test of cure), for up to 4 weeks
measure: Change in Serum Total Creatine Phosphokinase (CPK)
timeFrame: baseline to TOC(test of cure), for up to 4 weeks
measure: Change in Urine pH
timeFrame: baseline to TOC(test of cure), for up to 4 weeks
measure: Shift in ECG
timeFrame: baseline to TOC(test of cure), for up to 4 weeks
Secondary outcomes:
measure: Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
timeFrame: baseline and TOC, for up to 4 weeks
measure: Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)
timeFrame: baseline and EOT(end of therapy), for up to 2 weeks
measure: Microbiological Response at TOC(Test of Cure)
timeFrame: baseline and TOC, for up to 4 weeks
measure: Microbiological Response at EOT(End of Therapy)
timeFrame: baseline and EOT, for up to 2 weeks
measure: Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)
timeFrame: baseline and TOC, for up to 4 weeks
measure: Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC
timeFrame: baseline and TOC(test of cure), for up to 4 weeks
measure: Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC
timeFrame: baseline and TOC(test of cure), for up to 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Chongqing
country: China
facility: Research Site
city: Dalian
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: Antibiotics Institute, Huashan Hospital Affilicated to Fudan University
name: Zhang Yingyuan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: