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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01700842
First received: October 3, 2012
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition
Bacterial Skin Diseases

Study Type: Observational
Official Title: Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Microbiological strains


Enrollment: 3000
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

clinical material form patients in geographically distinct Russian cities

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700842

Locations
Russian Federation
Research Site
Saint-Petersburg, Russian Federation
Research Site
Smolensk, Russian Federation
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01700842     History of Changes
Other Study ID Numbers: NIS-IRU-XXX-2012/1
Study First Received: October 3, 2012
Last Updated: June 26, 2013
Health Authority: Russia: SUBMISSION NOT REQUIRED

Keywords provided by AstraZeneca:
ceftaroline, infection, CAPB, CAP, ABSSSI, cSSTI

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014