NCT04055675

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

August 12, 2019

Results QC Date

June 2, 2020

Last Update Submit

June 2, 2020

Conditions

Asymptomatic BacteriuriaAsymptomatic Pyuria

Outcome Measures

Primary Outcomes (1)

  • 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".

    The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.

Secondary Outcomes (1)

  • Incidental Hematuria

    The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.

Study Arms (2)

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.

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.

Diagnostic Test: Urine dipstick test

Interventions

Urine dipstick testDIAGNOSTIC_TEST

A sample of urine will be tested using a Mission Urinalysis Reagent Strip.

Asymptomatic Female VolunteersAsymptomatic Male Volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are all healthy volunteers, who are primarily family, friends, or acquaintances of study investigators.

You may qualify if:

  • Age \> 18 years
  • Able to spontaneously provide a urine sample

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kendall Regional Medical Center

Miami, Florida, 33175, United States

Location

Related Publications (4)

  • 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.

    PMID: 11018165BACKGROUND

  • Kunin 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.

    PMID: 4866351BACKGROUND

  • Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6. No abstract available.

    PMID: 10951726BACKGROUND

  • Frazee 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.

    PMID: 25841289BACKGROUND

Results Point of Contact

Title
Dr. Tony Zitek
Organization
Kendall Regional Medical Center
zitek10@gmail.com
305-480-6602

Study Officials

  • Tony Zitek, MD

    Nova Southeastern University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

July 3, 2019

Primary Completion

December 30, 2019

Study Completion

January 2, 2020

Last Updated

June 18, 2020

Results First Posted

June 18, 2020

Record last verified: 2020-06

Locations

US(1)