POCARED Diagnostics, LTD, Field Study Protocol

Urinary Tract Infections Clinical Trial

Official title:

POCARED Diagnostics, LTD, Field Study Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01487148
• Other study ID #: POCARED001
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2011
• Last updated: December 6, 2011
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2011
• Source: Pocared Diagnostics
• Contact: Jonathan Gurfinkel
• Phone: 972-8-6999779
• Email: jonathan.gurfinkel[@]pocared.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 and identification.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40000
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Tract Infections

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pocared Diagnostics

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement	Agreement of the POCARED quantification and identification compared with standard methods.	6 months	No
Primary	Sensitivity	Sensitivity of the POCARED quantification and identification compared with standard methods.	6 months	No
Primary	Specificity	Specificity of the POCARED quantification and identification compared with standard methods.	6 months	No