Status:
UNKNOWN
POCARED Diagnostics, LTD, Field Study Protocol
Lead Sponsor:
Pocared Diagnostics
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
Brief Summary
This study is designed to compare the performance of the P-1000 System, POCARED's Rapid Diagnostic System which uses optical fluorescence analysis, to standard methods of uropathogen quantification an...
Detailed Description
This study will be conducted at 5 sites, 4 in the United States and 1 site in Israel. 40,000 clinical specimens will be included and assessed by the laboratories using standard reference methods and t...
Eligibility Criteria
Inclusion
- Samples arriving in the laboratory for urine culture
Exclusion
- Samples \<=2mL
- Specimens stored at room temperature for more than 2 hours (unless a preservative is used)
- Specimens refrigerated for more than 24 hours
- Specimens requesting low count urine culture (\<100,000 CFU/mL \[colony forming units per milliliter\])
- Bloody specimens
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
40000 Patients enrolled
Trial Details
Trial ID
NCT01487148
Start Date
December 1 2011
End Date
June 1 2012
Last Update
December 7 2011
Active Locations (5)
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1
Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories
North Hollywood, California, United States, 91367
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214