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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01700842
• Collaborator: (none)
• Enrollment: 3,000
• Locations: 2
• Duration (Months): 2
• Patients Per Site: 1500
• Patients Per Site Per Month: 748.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Skin Diseases

Study Design

• Study Type: Observational
• Actual Enrollment: 3000 participants
• Official Title: Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Outcome Measures

Primary Outcome Measures

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. [up to 3 months]

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

Secondary Outcome Measures

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) [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 [upto 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Saint-Petersburg		Russian Federation
2	Research Site	Smolensk		Russian Federation

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01700842
• Other Study ID Numbers: NIS-IRU-XXX-2012/1
• First Posted: Oct 4, 2012
• Last Update Posted: Jun 27, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by AstraZeneca: ceftaroline, infection, CAPB, CAP, ABSSSI, cSSTI
• Additional relevant MeSH terms: Skin Diseases, Bacterial; Skin Diseases

Study Results

No Results Posted as of Jun 27, 2013