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POCARED Diagnostics, LTD, Field Study Protocol

This study is not yet open for participant recruitment.
Verified December 2011 by Pocared Diagnostics
Sponsor:
Information provided by (Responsible Party):
Pocared Diagnostics
ClinicalTrials.gov Identifier:
NCT01487148
First received: December 2, 2011
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Urinary Tract Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: POCARED Diagnostics, LTD, Field Study Protocol

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pocared Diagnostics:

Primary Outcome Measures:
  • Agreement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Agreement of the POCARED quantification and identification compared with standard methods.

  • Sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Sensitivity of the POCARED quantification and identification compared with standard methods.

  • Specificity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Specificity of the POCARED quantification and identification compared with standard methods.


Biospecimen Retention:   None Retained

Samples are de-identified leftover samples.


Estimated Enrollment: 40000
Study Start Date: December 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487148

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

Locations
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.            
Israel
Chaim Sheba Medical Center Not yet recruiting
Tel Aviv, Israel
Principal Investigator: Gill Smollan, M.D.            
Sponsors and Collaborators
Pocared Diagnostics
Investigators
Study Director: Jonathan Gurfinkel POCARED Diagnostics, Ltd.
  More Information

No publications provided

Responsible Party: Pocared Diagnostics
ClinicalTrials.gov Identifier: NCT01487148     History of Changes
Other Study ID Numbers: POCARED001
Study First Received: December 2, 2011
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013