Urinary Tract InfectionsNCT01487148
POCARED Diagnostics, LTD, Field Study Protocol
An observational study of Urinary Tract Infections, run by Pocared Diagnostics at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 40,000 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: At least 70 consecutive leftover and de-identified urine samples arriving in the laboratory each day for culture will be tested.
Who may be able to join
- Samples arriving in the laboratory for urine culture
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Gerri S. Hall, Ph.D
Riverside Methodist Hospital
Columbus, Ohio, 43214
Sue Fuhrman, M.D.
Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories
North Hollywood, California, 91367
Beth M. Marlowe, Ph.D.
Mayo Clinic
Rochester, Minnesota, 55905
Robin Patel, M.D.
About this study
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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement
Agreement of the POCARED quantification and identification compared with standard methods.
Measured: 6 months
Sensitivity
Sensitivity of the POCARED quantification and identification compared with standard methods.
Measured: 6 months
Specificity
Specificity of the POCARED quantification and identification compared with standard methods.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pocared Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Gurfinkel, Study director, POCARED Diagnostics, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487148
- Sponsor's protocol ID
- POCARED001
- Status last verified
- Dec 2011
- First submitted
- 2 Dec 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POCARED Diagnostics, LTD, Field Study Protocol
- ClinicalTrials.gov ID
- NCT01487148
- Acronym / sponsor ID
- POCARED001
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Pocared DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- At least 70 consecutive leftover and de-identified urine samples arriving in the laboratory each day for culture will be tested.
Key inclusion criteria (1 listed)
- Samples arriving in the laboratory for urine culture
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement
Time frame: 6 months
Agreement of the POCARED quantification and identification compared with standard methods.
Sensitivity
Time frame: 6 months
Sensitivity of the POCARED quantification and identification compared with standard methods.
Specificity
Time frame: 6 months
Specificity of the POCARED quantification and identification compared with standard methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
Related trials for Urinary Tract Infections
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
Active, not recruitingObservational study
The Impact of De-implementing Urine Dipsticks for Diagnosis of UTIs in Hospitals
Urinary Tract Infections, Diagnostic Techniques and Procedures
RecruitingPhase 3
Precision Management of Urinary Tract Symptoms in Older Women
Urinary Tract Infection (Diagnosis)
Enrolling by invitation
VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST
Common Infections, Urinary Tract Infections
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Gurfinkel study director
POCARED Diagnostics, Ltd.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Pocared Diagnostics at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Gurfinkel (972-8-6999779, jonathan.gurfinkel@pocared.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2011.