Completed
CERBERUSMulticenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
What is being collected
Data Collection
No Sample Retained
Who is being recruted
Bacterial Infections and Mycoses+4
+ Bacterial Infections
+ Skin Diseases
+8 Eligibility Criteria
How is the trial designed
Observational
Study Start: October 2012
Summary
Principal SponsorAstraZeneca
Last updated: June 27, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorAstraZeneca
Last updated: June 27, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
3000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bacterial Infections and MycosesBacterial InfectionsSkin DiseasesSkin Diseases, InfectiousSkin and Connective Tissue DiseasesInfectionsSkin Diseases, Bacterial
Criteria
6 inclusion criteria required to participate
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
Isolates collected retro- and prospectively will be included in the study (from 01.01.2008 till 31.12.2012)
Show More Criteria
2 exclusion criteria prevent from participating
ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum beta-lactamase)
Isolates, arrived in the central laboratory contaminated or unviable
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Research Site
Smolensk, RussiaCompleted2 Study Centers