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

NCT01700842 | Completed

• 1 other identifier: NIS-IRU-XXX-2012/1
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Bacterial Skin Diseases

Keywords

ceftaroline, infection, CAPB, CAP, ABSSSI, cSSTI

Outcome Measures

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.

  MIC- Minimum inhibitory concentration; EUCAST - European Committee on Antimicrobial Susceptibility Testing; CLSI- Clinical and Laboratory Standard Institute

  up to 3 months

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

clinical material form patients in geographically distinct Russian cities

You may qualify if:

• 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

You may not qualify if:

• ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum beta-lactamase)
• Isolates, arrived in the central laboratory contaminated or unviable

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Saint Petersburg, Russia

Location

Research Site

Smolensk, Russia

Location

Biospecimen

Retention: NONE RETAINED

Microbiological strains

MeSH Terms

Conditions

Skin Diseases, Bacterial; Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

RU (2)