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

Primary Purpose

Bacterial Skin Diseases

Status

Completed

Phase

Locations

Russian Federation

Study Type

Observational

Intervention

About this trial

This is an observational trial for Bacterial Skin Diseases focused on measuring ceftaroline, infection, CAPB, CAP, ABSSSI, cSSTI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site

Outcomes

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.

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)

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

Full Information

NCT ID

NCT01700842

First Posted

October 3, 2012

Last Updated

June 26, 2013

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01700842

Brief Title

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

Acronym

CERBERUS

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Skin Diseases

Keywords

ceftaroline, infection, CAPB, CAP, ABSSSI, cSSTI

7. Study Design

Enrollment

3000 (Actual)

Biospecimen Retention

None Retained

Biospecimen Description

Microbiological strains

Primary Outcome Measure Information:

Title

Description

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

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

Time Frame

up to 3 months

Title

Time Frame

upto 3 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Study Population Description

clinical material form patients in geographically distinct Russian cities

Sampling Method

Probability Sample

Facility Information:

Facility Name

Research Site

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Smolensk

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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