Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03163394 · ClinicalTrials.gov registry record
HD5 Levels in Catheter Versus Bag Urine Specimens in Young Children for the Diagnosis of UTI
A clinical trial, sponsored by Le Bonheur Children's Hospital.
- Terminated
- Registry status
- 5
- Enrollment target
NCT03163394: Clinical Trial study, sponsored by Le Bonheur Children's Hospital.
NCT03163394 is a clinical trial that was terminated before completion, run by Le Bonheur Children's Hospital. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03163394 was terminated before completion, sponsored by Le Bonheur Children's Hospital.
- TERMINATED
- Registry status
- 5 participants
- Enrollment target
Study Summary
Urinary tract infections (UTIs) are a common cause of bacteremia and serious bacterial infections in young children (2-24 months of age). Because these children are usually unable to say what symptoms they are experiencing, UTIs are diagnosed through testing. Current testing of urine samples require a catheter or suprapubic aspiration performed for urine collection for infections markers to be reliable. Bag specimens often have varying results that can be poor in sensitivity and specificity depending on what component of the urine test one is looking at. Catheter and aspiration testing can be anxiety-provoking to parents, be painful for patients and even introduce bacteria into the bladder. An antimicrobial peptide called alpha human defensin-5 (HD5) is produced by the uroepithelium in response to infection. HD5 has been studied in the urine and does increase in actual UTIs. This study will look at children 1 to 24 months of age and again study levels of HD5 in culture positive UTIs versus urine negative for UTI. This study will also determine if collection method alters HD5 levels. We will measure HD5 levels in the urine from a bag specimen and a catheter specimen in the same patient. Our primary objective is to determine the sensitivity and specificity of HD5 measured in urine collected by bag and catheter in the same patient for the diagnosis of UTI in children between the age 1 to 24 months presenting with febrile illness and suspected UTI.
Primary Outcome
The sensitivity and specificity of HD5 in determining urinary tract infections in bag versus catheter specimens in children aged 1 to 24 months
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-04-23 |
| Est. Completion | 2019-06-10 |
Why NCT03163394 stopped before completion
NCT03163394 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03163394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03163394 about?
NCT03163394 is a clinical study titled "HD5 Levels in Catheter Versus Bag Urine Specimens in Young Children for the Diagnosis of UTI". Urinary tract infections (UTIs) are a common cause of bacteremia and serious bacterial infections in young children (2-24 months of age). Because these children are usually unable to say what symptoms they are experiencing, UTIs are diagnosed through testing. Current testing of urine samples require...
What is the current status of trial NCT03163394?
This trial is currently terminated. The enrollment target is 5 participants. The study started on 2017-04-23. Estimated completion is 2019-06-10.
Who is sponsoring clinical trial NCT03163394?
This trial is sponsored by Le Bonheur Children's Hospital, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI