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POCARED Diagnostics, LTD, Field Study Protocol

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ClinicalTrials.gov Identifier: NCT01487148
Recruitment Status : Unknown
Verified December 2011 by Pocared Diagnostics.
Recruitment status was:  Not yet recruiting
First Posted : December 7, 2011
Last Update Posted : December 7, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 40000 participants
Time Perspective: Prospective
Official Title: POCARED Diagnostics, LTD, Field Study Protocol
Study Start Date : December 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Agreement [ Time Frame: 6 months ]
    Agreement of the POCARED quantification and identification compared with standard methods.

  2. Sensitivity [ Time Frame: 6 months ]
    Sensitivity of the POCARED quantification and identification compared with standard methods.

  3. Specificity [ Time Frame: 6 months ]
    Specificity of the POCARED quantification and identification compared with standard methods.

Biospecimen Retention:   None Retained
Samples are de-identified leftover samples.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487148

Contact: Jonathan Gurfinkel 972-8-6999779 jonathan.gurfinkel@pocared.com

United States, California
Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories Not yet recruiting
North Hollywood, California, United States, 91367
Principal Investigator: Beth M. Marlowe, Ph.D.         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Robin Patel, M.D.         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Gerri S. Hall, Ph.D         
Riverside Methodist Hospital Not yet recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Sue Fuhrman, M.D.         
Chaim Sheba Medical Center Not yet recruiting
Tel Aviv, Israel
Principal Investigator: Gill Smollan, M.D.         
Sponsors and Collaborators
Pocared Diagnostics
Study Director: Jonathan Gurfinkel POCARED Diagnostics, Ltd.
More Information

Responsible Party: Pocared Diagnostics
ClinicalTrials.gov Identifier: NCT01487148     History of Changes
Other Study ID Numbers: POCARED001
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: December 7, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases