POCARED Diagnostics, LTD, Field Study Protocol

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01487148

Enrollment

40000

Registered

2011-12-07

Start date

2011-12-31

Completion date

2012-06-30

Last updated

2011-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

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 and identification.

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Israel, United States

Contacts

Primary ContactJonathan Gurfinkel

jonathan.gurfinkel@pocared.com972-8-6999779

Outcome results