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

June 26, 2013 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation
        • Research Site
      • Smolensk, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

clinical material form patients in geographically distinct Russian cities

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
upto 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (ESTIMATE)

October 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-IRU-XXX-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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