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Trial record 63 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

HD5 Levels in Catheter Versus Bag Urine Specimens in Young Children for the Diagnosis of UTI

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ClinicalTrials.gov Identifier: NCT03163394
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : March 9, 2018
Sponsor:
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

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 450 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
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03163394


Contacts
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Contact: Kristy Morse, MD 901-352-0551 kmorse1@uthsc.edu

Locations
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United States, Tennessee
LeBonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Kristy Morse, MD    901-352-0551    kmorse1@uthsc.edu   
Sponsors and Collaborators
Le Bonheur Children's Hospital
Investigators
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Principal Investigator: Kristy Morse UTHSC

Publications:

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Responsible Party: Kristy Morse, Principal Investigator, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT03163394     History of Changes
Other Study ID Numbers: HD52017
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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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
Infection
Urologic Diseases