HD5 Levels in Catheter Versus Bag Urine Specimens in Young Children for the Diagnosis of UTI
Stopped early
Conditions studied: Urinary Tract Infections
In brief
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.
Key facts
- Study ID
- NCT03163394
- Run by
- Le Bonheur Children's Hospital
- People needed
- 5
- Starts
- 2017-04-23
- Expected to finish
- 2019-06-10
- Last updated by the study team
- 2020-02-27
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient is between 1 to 24 months of age Patient has reported or measured fever >38.5 degrees C (101.3 degrees F)
You may not qualify if…
- RSV Positive at time of urine collection Flu Positive at time of urine collection Known GU abnormality Neurogenic bladder Frequent catheterizations Indwelling catheter Antibiotics in the last 7 days
Where it is running
- LeBonheur Children's Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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