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Completed

NCT Number: NCT01700842

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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Key information

Conditions

Bacterial Skin Diseases Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Saint Petersburg, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: CERBERUS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Jun 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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