Urinary Tract Infections in ChildrenNCT04763967
A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.
An observational study of Urinary Tract Infections in Children, run by Big Blue Biotech, Inc. at 1 site in United States.
Trial 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will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling Catheter. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Urinary Tract Infections in Children
- What is being tested?
- PedSCath Pediatric Urinary Catheter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 2 Feb 2023
- 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Prospective cohort subjects will enter the emergency department presenting symptoms of UTI. The Control group will be retrospectively enrolled by gathering data through anonymized 2016 and 2018 subject data gathered from the study's clinical sites.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian Queens
New York, New York, 11355
About this study
Official title: A Multi-center, Study of the Non-inferiority of PedSCath Pediatric Sampling Catheter Versus a Retrospective Control Cohort Using Current Standard of Care.
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.
Read the detailed description
This will be a multi-center, retrospective-controlled, clinical trial.
Anonymized retrospective data from two clinical sites, NewYork-Presbyterian Queens and Weill Cornell Medical College, from 2016 and 2018 will be used to define the control subject population, who were assessed for urinary tract infection (UTI) based on a urine sample taken according to Standard of Care (SoC).
Subjects entering the emergency department (ED) generally require that a urine specimen is obtained and tested to determine whether there is an active infection in the bladder. Emergency department personnel will confirm the possibility of UTI based on symptoms and inform the parents/guardians of the potential for study participation using the PedSCath. The physician will assess the subject based on Inclusion and Exclusion criteria, including non-toilet training and an upper age limit of 3 years. If determined that the subject meets inclusion/exclusion criteria, the physician will inform the parents/guardians of the subject about the study and request informed consent if the parents/guardians wish their child to participate.
Following the granting of Informed Consent, subjects will be enrolled in the study within the treatment arm and a urine sample of 2-3 ml will be taken via the PedSCath. All study assessments, from enrollment through urine sample collection, will occur over a single visit to the ED. Per standard of care, any treatment following the diagnosis will be performed by hospital staff based on physician assessment. Up to 3 run-in subjects per PedSCath user will be treated with PedSCath to allow PedSCath users to become familiar with PedSCath mechanism.
- Conditions
- Urinary Tract Infections in Children
- Being tested
- PedSCath Pediatric Urinary Catheter, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedSCath Pediatric Urinary CatheterDevice
Also called Wiygul Catheter
PedSCath Pediatric Sampling Catheter is a pediatric sampling catheter. The product is supplied as a catheter and syringe. PedSCath Pediatric Sampling Catheter is manufactured by Medical Murray Inc. for Big Blue Biotech. The device consists of a blend of LDPE/Elvax/Crodamide.
Standard of CareDevice
Current Standard of Care for pediatric patients
| Study group | Role | What they receive |
|---|---|---|
| PedSCath | Subjects in this arm will be catheterized with the PedSCath Pediatric Urinary Cather. Receives: Device: PedSCath Pediatric Urinary Catheter | |
| Retrospective Control | Generated from 2016 and 2018 anonymized subject data from the clinical sites. Receives: Device: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects.
The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects. The objective is to demonstrate a lower rate of positive urinalysis/urine culture results in the PedSCath cohort.
Measured: Through study completion, an estimation of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start27 Aug 2021
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Why it stopped: Slow Enrollment, Recruiting Difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections in ChildrenStudies 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
- Other
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Big Blue Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evan M Haynes, MA, Study chair, Big Blue Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763967
- Sponsor's protocol ID
- BBBInc: 0619
- Status last verified
- Jun 2023
- First submitted
- 2 Dec 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Study of the Non-inferiority of PedSCath Pediatric Sampling Catheter Versus a Retrospective Control Cohort Using Current Standard of Care.
- ClinicalTrials.gov ID
- NCT04763967
- Acronym / sponsor ID
- BBBInc: 0619
- Conditions
- Urinary Tract Infections in Children
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow Enrollment, Recruiting Difficulties
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Big Blue Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- 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 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.
Detailed description
This will be a multi-center, retrospective-controlled, clinical trial.
Anonymized retrospective data from two clinical sites, NewYork-Presbyterian Queens and Weill Cornell Medical College, from 2016 and 2018 will be used to define the control subject population, who were assessed for urinary tract infection (UTI) based on a urine sample taken according to Standard of Care (SoC).
Subjects entering the emergency department (ED) generally require that a urine specimen is obtained and tested to determine whether there is an active infection in the bladder. Emergency department personnel will confirm the possibility of UTI based on symptoms and inform the parents/guardians of the potential for study participation using the PedSCath. The physician will assess the subject based on Inclusion and Exclusion criteria, including non-toilet training and an upper age limit of 3 years. If determined that the subject meets inclusion/exclusion criteria, the physician will inform the parents/guardians of the subject about the study and request informed consent if the parents/guardians wish their child to participate.
Following the granting of Informed Consent, subjects will be enrolled in the study within the treatment arm and a urine sample of 2-3 ml will be taken via the PedSCath. All study assessments, from enrollment through urine sample collection, will occur over a single visit to the ED. Per standard of care, any treatment following the diagnosis will be performed by hospital staff based on physician assessment. Up to 3 run-in subjects per PedSCath user will be treated with PedSCath to allow PedSCath users to become familiar with PedSCath mechanism.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PedSCath | – | Device: PedSCath Pediatric Urinary CatheterSubjects in this arm will be catheterized with the PedSCath Pediatric Urinary Cather. |
| Retrospective Control | – | Device: Standard of CareGenerated from 2016 and 2018 anonymized subject data from the clinical sites. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Prospective cohort subjects will enter the emergency department presenting symptoms of UTI. The Control group will be retrospectively enrolled by gathering data through anonymized 2016 and 2018 subject data gathered from the study's clinical sites.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PedSCath Pediatric Urinary CatheterAlso: Wiygul CatheterPedSCath Pediatric Sampling Catheter is a pediatric sampling catheter. The product is supplied as a catheter and syringe. PedSCath Pediatric Sampling Catheter is manufactured by Medical Murray Inc. for Big Blue Biotech. The device consists of a blend of LDPE/Elvax/Crodamide. | Device | PedSCath |
| Standard of CareCurrent Standard of Care for pediatric patients | Device | Retrospective Control |
Primary outcome
The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects.
Time frame: Through study completion, an estimation of 1 year.
The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects. The objective is to demonstrate a lower rate of positive urinalysis/urine culture results in the PedSCath cohort.
Results and safety
The study was stopped early (reason given: Slow Enrollment, Recruiting Difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
Evan M Haynes, MA study chair
Big Blue Biotech, Inc.
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 Urinary Tract Infections in Children, run by Big Blue Biotech, Inc. 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 4 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: stopped early, as of the sponsor's last update on 22 Jun 2023. 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?
The study was stopped early (reason given: Slow Enrollment, Recruiting Difficulties). Results are not available in the source record.
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?
The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects. (time frame: Through study completion, an estimation of 1 year.). 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 22 Jun 2023.