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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. Identifier: NCT03163394
Recruitment Status : Terminated (Did not enroll enough patients for study)
First Posted : May 23, 2017
Last Update Posted : February 27, 2020
Information provided by (Responsible Party):
Kristy Morse, Le Bonheur Children's Hospital

Brief 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.

Condition or disease
Urinary Tract Infections

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children between the age of 1 to 24 months that present to the LeBonheur Emergency Room with fever of 38.5 degrees Celsius by report or on measurement will have urine bag placed. If patient has urinalysis and urine culture ordered because of suspicion for UTI and patient has voided in the bag, then patient's family will be approached for research

Inclusion Criteria:

Patient is between 1 to 24 months of age Patient has reported or measured fever >38.5 degrees C (101.3 degrees F)

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03163394

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United States, Tennessee
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
Le Bonheur Children's Hospital
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Principal Investigator: Kristy Morse UTHSC

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Responsible Party: Kristy Morse, Principal Investigator, Le Bonheur Children's Hospital Identifier: NCT03163394    
Other Study ID Numbers: HD52017
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Urologic Diseases