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
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 April 21, 2014
Urinary Tract Infections