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

NCT03163394 | Terminated

• 1 other identifier: HD52017
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of HD5 as marker for UTI

  The sensitivity and specificity of HD5 in determining urinary tract infections in bag versus catheter specimens in children aged 1 to 24 months

  1 year

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• 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

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

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead

Study Sites (1)

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Related Publications (19)

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  PMID: 26375724 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kristy Morse

  UTHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 23, 2017
• Study Start: April 23, 2017
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

US (1)