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Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia (CERBERUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700842
First Posted: October 4, 2012
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
October 3, 2012
October 4, 2012
June 27, 2013
October 2012
December 2012   (Final data collection date for primary outcome measure)
Percentage(numerical) MIC distribution of microorganisms for ceftaroline and other tested antimicrobials, including MIC50 and MIC90, percent(quantity)of susceptible and resistant strains in accordance with EUCAST or CLSI recommended breakpoints. [ Time Frame: up to 3 months ]
MIC- Minimum inhibitory concentration; EUCAST - European Committee on Antimicrobial Susceptibility Testing; CLSI- Clinical and Laboratory Standard Institute
Percentage(numerical) MIC distribution of microorganisms for ceftaroline and other tested antimicrobials, including MIC50 and MIC90, percent(quantity)of susceptible and resistant strains in accordance with EUCAST or CLSI recommended breakpoints. [ Time Frame: up to 3 months ]
Complete list of historical versions of study NCT01700842 on ClinicalTrials.gov Archive Site
  • Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains, to tested antibiotics depend on: infection localization, medical condition, ward/unit profile,patient profile(age) [ Time Frame: up to 3 months ]
  • Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains,to ceftaroline and other antimicrobials by years from 2008 to 2012 [ Time Frame: upto 3 months ]
Same as current
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Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
Approximately 3,000 of clinically significant isolates of different species from respective respective sources in geographically distinct Russian cities will be collected and tested on ceftaroline and other antimicrobials.
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Observational
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Retention:   None Retained
Description:
Microbiological strains
Probability Sample
clinical material form patients in geographically distinct Russian cities
Bacterial Skin Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Isolates derived from patients' clinical material will be included in the study
  • Isolates collected retro- and prospectively will be included in the study (from 01.01.2008 till 31.12.2012)
  • Isolates, allocated of a clinical material of adult patients (> 18 years), should make not less than 70 % from total number of included isolates)
  • All included isolates should be unique: only one isolate can be included in the study of each biological type from each patient
  • All isolates should correspond to clinic-laboratory criteria of the etiologic importance, i.e. should be derived from patients with infection symptoms from the corresponding clinical material
  • Case report form (CRF) (Appendix 1) should be correctly completed for each isolate

Exclusion Criteria:

  • ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum beta-lactamase)
  • Isolates, arrived in the central laboratory contaminated or unviable
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT01700842
NIS-IRU-XXX-2012/1
Not Provided
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Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
June 2013