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

Bacterial Skin Diseases Clinical Trial

— CERBERUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700842
• Other study ID #: NIS-IRU-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: June 26, 2013
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: SUBMISSION NOT REQUIRED
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Bacterial Skin Diseases
• Skin Diseases
• Skin Diseases, Bacterial

Locations

Country	Name	City	State
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Smolensk

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No