HD5 Levels in Catheter Versus Bag Urine Specimens in Young Children for the Diagnosis of UTI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03163394|
Recruitment Status : Terminated (Did not enroll enough patients for study)
First Posted : May 23, 2017
Last Update Posted : February 27, 2020
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.
|Condition or disease|
|Urinary Tract Infections|
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||HD5 Levels in Catheter Versus Bag Urine Specimens in Young Children for the Diagnosis of UTI|
|Actual Study Start Date :||April 23, 2017|
|Actual Primary Completion Date :||June 10, 2019|
|Actual Study Completion Date :||June 10, 2019|
- Sensitivity and specificity of HD5 as marker for UTI [ Time Frame: 1 year ]The sensitivity and specificity of HD5 in determining urinary tract infections in bag versus catheter specimens in children aged 1 to 24 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163394
|United States, Tennessee|
|LeBonheur Children's Hospital|
|Memphis, Tennessee, United States, 38103|
|Principal Investigator:||Kristy Morse||UTHSC|