TerminatedNot Applicable

A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.

Stopped: Slow Enrollment, Recruiting Difficulties

United States2 participantsStarted 2021-08-27

Plain-language summary

This is a retrospectively-controlled clinical trial that will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling Catheter. The rate of postive UTI will be compared against the control population, whose urine withdrawal would have been performed with Standard of Care devices.

Who can participate

Age range

3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is 3 years of age or younger. * Subject is non-toilet trained, as communicated by subject's parent/guardian. * Subject is presenting to the emergency department with symptoms for UTI, as described by AAP guidelines (Newborns with UTI may present with jaundice, sepsis, failure to thrive, vomiting, or fever. In infants and young children, typical signs and symptoms include fever, strong-smelling urine, hematuria, abdominal or flank pain, and new-onset urinary incontinence) or as determined by PI. * Subject's parent/guardian is able to provide informed consent. Exclusion Criteria: * Any subject with known underlying abnormalities to the genitourinary tract (e.g. prenatal hydronephrosis). * Any subject who has had prior genitourinary tract or abdominal surgery. * Any subject who is toilet trained (i.e. able to provide a clean catch urine sample). * Any subject with an active rash or skin lesion in the suprapubic area. * Any subject with a known allergy to LDPE, Elvax, or Crodamide plastics.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects.

Timeframe: Through study completion, an estimation of 1 year.

Trial details

NCT IDNCT04763967

SponsorBig Blue Biotech, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-02-02

View on ClinicalTrials.gov More Urinary Tract Infections in Children trials