Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed,
and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government
operating status and resumption of normal operations can be found at opm.gov.
Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia (CERBERUS)
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.
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.
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
Secondary Outcome Measures
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
clinical material form patients in geographically distinct Russian cities
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
ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum beta-lactamase)
Isolates, arrived in the central laboratory contaminated or unviable