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

Completed

• Conditions: Bacterial Skin Diseases

• Registration Number: NCT01700842
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	up to 3 months	MIC- Minimum inhibitory concentration; EUCAST - European Committee on Antimicrobial Susceptibility Testing; CLSI- Clinical and Laboratory Standard Institute

Secondary Outcome Measures

Name	Time	Method
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)	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	upto 3 months

Trial Locations

Locations (1)

Research Site; 🇷🇺 Smolensk, Russian Federation