POCARED Diagnostics, LTD, Field Study Protocol

Status unconfirmed

Conditions studied: Urinary Tract Infections

In brief

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 and identification.

Key facts

Study ID

NCT01487148

Run by

Pocared Diagnostics

People needed

40000

Starts

2011-12-01

Expected to finish

2012-06-01

Last updated by the study team

2011-12-07

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Samples arriving in the laboratory for urine culture

You may not qualify if…

• 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

Where it is running

• Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories — North Hollywood, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Chaim Sheba Medical Center — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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