Asymptomatic BacteriuriaNCT04055675
Urinalysis Results in Healthy Individuals
An observational study of Asymptomatic Bacteriuria and Asymptomatic Pyuria, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
Trial summary
This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Bacteriuria, Asymptomatic Pyuria
- What is being tested?
- Urine dipstick test
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2019to 2 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are all healthy volunteers, who are primarily family, friends, or acquaintances of study investigators.
Who may be able to join
- Age > 18 years
- Able to spontaneously provide a urine sample
Who cannot join
- Any acute symptoms (including but not limited to vaginal bleeding, vaginal discharge, abdominal pain, back pain, dysuria, hematuria, and fever)
- Pregnancy
- Prisoner status
- Antibiotics within 72 hours
- Urologic procedure within a week
Trial locations and contacts
1 site in 1 country.
United States1 site
Kendall Regional Medical Center
Miami, Florida, 33175
About this study
Official title: The Frequency of Leukocytes and Nitrites in the Urine of Healthy Adults
This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.
Read the detailed description
The urinalysis (UA) is one of the most commonly utilized tests in the emergency department (ED). In some busy EDs, a UA is routinely ordered by protocol on patients with abdominal pain, and in elderly patients, a UA is often ordered for a variety of chief complaints including dizziness and altered mental status. When these patients, who often do not specifically have symptoms of a urinary tract infection, have a urinalysis demonstrating pyuria or bacteria, it may be interpreted as an atypical presentation of a UTI. However, it is possible that these patients do not have urinary tract infections, but have baseline pyuria or bacteriuria. One prior study found that 5% of sexually active healthy women 18-40 have asymptomatic bacteriuria [1], and the rate of asymptomatic bacteriuria increases with age, such that it is present in 8-10% of women from 70-80 years of age [2]. Moreover, one prior article stated that 30-50% of residents of long term nursing facilities have positive urine cultures at any given time [3].
The above statistics come from the results of urine cultures. In the ED, the decision to treat or not treat a patient for a UTI is not made based upon culture results, but upon a urinalysis (microscopic or dipstick). Only one prior study has looked at the frequency of abnormal urinalyses in healthy individuals, and it found that over a third of asymptomatic women had at least 1+ leukocytes in their urine [4]. This is evidence that a substantial number of people who do not have symptomatic UTIs have UAs that could be interpreted as UTIs. If these results could be replicated and expanded to include a wider group of individuals (males, elderly patients, various races, etc.), it would provide valuable information about how we can better interpret and utilize the results of a UA.
Thus, the investigators propose a prospective study to assess the frequency of abnormal UAs in a wide variety of individuals without acute symptoms.
Urine samples will be obtained from adults with no acute symptoms, and performed urine dipsticks to assess the frequency of leukocytes or nitrites in the urine. Patients will be divided into groups to determine if there are certain factors (gender, age, or medical history) that increase the chance of having leukocytes or nitrites in the urine.
- Conditions
- Asymptomatic Bacteriuria, Asymptomatic Pyuria
- Being tested
- Urine dipstick test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine dipstick testDiagnostic test
A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Male Volunteers | These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male. Receives: Diagnostic Test: Urine dipstick test | |
| Asymptomatic Female Volunteers | These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female. Receives: Diagnostic Test: Urine dipstick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
False Positive Urine
A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a "false positive urine".
Measured: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.
Secondary outcomes (1)
Incidental Hematuria
A urine sample with any blood on urine dipstick test will be considered to have "incidental hematuria"
Measured: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start3 Jul 2019
- Primary completion30 Dec 2019
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic BacteriuriaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kendall Healthcare Group, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Zitek, MD, Study director, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055675
- Sponsor's protocol ID
- 2019-356 Non-NSU Health
- Status last verified
- Jun 2020
- First submitted
- 12 Aug 2019
- Last updated
- 18 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hooton TM, Scholes D, Stapleton AE, Roberts PL, Winter C, Gupta K, Samadpour M, Stamm WE. A prospective study of asymptomatic bacteriuria in sexually active young women. N Engl J Med. 2000 Oct 5;343(14):992-7. doi: 10.1056/NEJM200010053431402.
PubMed 11018165Kunin CM, McCormack RC. An epidemiologic study of bacteriuria and blood pressure among nuns and working women. N Engl J Med. 1968 Mar 21;278(12):635-42. doi: 10.1056/NEJM196803212781201. No abstract available.
PubMed 4866351Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6. No abstract available.
PubMed 10951726Frazee BW, Enriquez K, Ng V, Alter H. Abnormal urinalysis results are common, regardless of specimen collection technique, in women without urinary tract infections. J Emerg Med. 2015 Jun;48(6):706-11. doi: 10.1016/j.jemermed.2015.02.020. Epub 2015 Apr 1.
PubMed 25841289
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Leukocytes and Nitrites in the Urine of Healthy Adults
- ClinicalTrials.gov ID
- NCT04055675
- Acronym / sponsor ID
- 2019-356 Non-NSU Health
- Conditions
- Asymptomatic Bacteriuria, Asymptomatic Pyuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kendall Healthcare Group, Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Posted 18 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.
Detailed description
The urinalysis (UA) is one of the most commonly utilized tests in the emergency department (ED). In some busy EDs, a UA is routinely ordered by protocol on patients with abdominal pain, and in elderly patients, a UA is often ordered for a variety of chief complaints including dizziness and altered mental status. When these patients, who often do not specifically have symptoms of a urinary tract infection, have a urinalysis demonstrating pyuria or bacteria, it may be interpreted as an atypical presentation of a UTI. However, it is possible that these patients do not have urinary tract infections, but have baseline pyuria or bacteriuria. One prior study found that 5% of sexually active healthy women 18-40 have asymptomatic bacteriuria [1], and the rate of asymptomatic bacteriuria increases with age, such that it is present in 8-10% of women from 70-80 years of age [2]. Moreover, one prior article stated that 30-50% of residents of long term nursing facilities have positive urine cultures at any given time [3].
The above statistics come from the results of urine cultures. In the ED, the decision to treat or not treat a patient for a UTI is not made based upon culture results, but upon a urinalysis (microscopic or dipstick). Only one prior study has looked at the frequency of abnormal urinalyses in healthy individuals, and it found that over a third of asymptomatic women had at least 1+ leukocytes in their urine [4]. This is evidence that a substantial number of people who do not have symptomatic UTIs have UAs that could be interpreted as UTIs. If these results could be replicated and expanded to include a wider group of individuals (males, elderly patients, various races, etc.), it would provide valuable information about how we can better interpret and utilize the results of a UA.
Thus, the investigators propose a prospective study to assess the frequency of abnormal UAs in a wide variety of individuals without acute symptoms.
Urine samples will be obtained from adults with no acute symptoms, and performed urine dipsticks to assess the frequency of leukocytes or nitrites in the urine. Patients will be divided into groups to determine if there are certain factors (gender, age, or medical history) that increase the chance of having leukocytes or nitrites in the urine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Male Volunteers | – | Diagnostic Test: Urine dipstick testThese are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male. |
| Asymptomatic Female Volunteers | – | Diagnostic Test: Urine dipstick testThese are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are all healthy volunteers, who are primarily family, friends, or acquaintances of study investigators.
Key inclusion criteria (2 listed)
- Age > 18 years
- Able to spontaneously provide a urine sample
Key exclusion criteria (5 listed)
- Any acute symptoms (including but not limited to vaginal bleeding, vaginal discharge, abdominal pain, back pain, dysuria, hematuria, and fever)
- Pregnancy
- Prisoner status
- Antibiotics within 72 hours
- Urologic procedure within a week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine dipstick testA sample of urine will be tested using a Mission Urinalysis Reagent Strip. | Diagnostic test | Asymptomatic Female Volunteers, Asymptomatic Male Volunteers |
Primary outcome
False Positive Urine
Time frame: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.
A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a "false positive urine".
1 secondary outcome
Incidental Hematuria
Time frame: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11018165Hooton TM, Scholes D, Stapleton AE, Roberts PL, Winter C, Gupta K, Samadpour M, Stamm WE. A prospective study of asymptomatic bacteriuria in sexually active young women. N Engl J Med. 2000 Oct 5;343(14):992-7. doi: 10.1056/NEJM200010053431402.
- Background: PubMed 4866351Kunin CM, McCormack RC. An epidemiologic study of bacteriuria and blood pressure among nuns and working women. N Engl J Med. 1968 Mar 21;278(12):635-42. doi: 10.1056/NEJM196803212781201. No abstract available.
- Background: PubMed 10951726Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6. No abstract available.
- Background: PubMed 25841289Frazee BW, Enriquez K, Ng V, Alter H. Abnormal urinalysis results are common, regardless of specimen collection technique, in women without urinary tract infections. J Emerg Med. 2015 Jun;48(6):706-11. doi: 10.1016/j.jemermed.2015.02.020. Epub 2015 Apr 1.
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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.
Tony Zitek, MD study director
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymptomatic Bacteriuria and Asymptomatic Pyuria, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False Positive Urine (time frame: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055675, which also lists 4 linked publications.
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 18 Jun 2020.