POCARED Diagnostics, LTD, Field Study Protocol

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infections

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 the P-1000.

• Study Type: Observational
• Enrollment (Anticipated): 40000

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Chaim Sheba Medical Center
• United States
  • California
    • North Hollywood, California, United States, 91367
      • Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

At least 70 consecutive leftover and de-identified urine samples arriving in the laboratory each day for culture will be tested.

Description

Inclusion Criteria:

• Samples arriving in the laboratory for urine culture

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement	Agreement of the POCARED quantification and identification compared with standard methods.	6 months
Sensitivity	Sensitivity of the POCARED quantification and identification compared with standard methods.	6 months
Specificity	Specificity of the POCARED quantification and identification compared with standard methods.	6 months

Collaborators and Investigators

• Sponsor: Pocared Diagnostics
• Investigators: Study Director: Jonathan Gurfinkel, POCARED Diagnostics, Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: December 2, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 7, 2011

Study Record Updates

• Last Update Posted (Estimate): December 7, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections
• Other Study ID Numbers: POCARED001