POCARED Diagnostics, LTD, Field Study Protocol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Pocared Diagnostics.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014