POCARED Diagnostics, LTD, Field Study Protocol
This study is not yet open for participant recruitment.
Verified December 2011 by Pocared Diagnostics
Information provided by (Responsible Party):
First received: December 2, 2011
Last updated: December 6, 2011
Last verified: December 2011
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.
||Time Perspective: Prospective
||POCARED Diagnostics, LTD, Field Study Protocol
Biospecimen Retention: None Retained
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.
Samples are de-identified leftover samples.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
At least 70 consecutive leftover and de-identified urine samples arriving in the laboratory each day for culture will be tested.
- Samples arriving in the laboratory for urine culture
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487148
|Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories
|North Hollywood, California, United States, 91367 |
|Principal Investigator: Beth M. Marlowe, Ph.D. |
|Rochester, Minnesota, United States, 55905 |
|Principal Investigator: Robin Patel, M.D. |
|Cleveland, Ohio, United States, 44195 |
|Principal Investigator: Gerri S. Hall, Ph.D |
|Riverside Methodist Hospital
|Columbus, Ohio, United States, 43214 |
|Principal Investigator: Sue Fuhrman, M.D. |
|Chaim Sheba Medical Center
|Tel Aviv, Israel |
|Principal Investigator: Gill Smollan, M.D. |
||POCARED Diagnostics, Ltd.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 2, 2011
||December 6, 2011
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Urinary Tract Infections