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NCT03163394
HD5 Levels in Catheter Versus Bag Urine Specimens in Young Children for the Diagnosis of UTI
trial in Urinary Tract Infections in 5 participants. Terminated before completion.
10 June 2019
Quick facts
| Lead sponsor | Le Bonheur Children's Hospital |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 5 |
| Start date | 23 April 2017 |
| Primary completion | 10 June 2019 |
| Estimated completion | 10 June 2019 |
| Sites | 1 location across United States |
Conditions studied
- Urinary Tract Infections — all drugs for Urinary Tract Infections →
Sponsor
Le Bonheur Children's Hospital
Who can join
Adults 1 Month to 24 Months, any sex, with Urinary Tract Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT03163394
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Other Le Bonheur Children's Hospital trials
Trials by the same sponsor.
- NCT04905563 — NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures · Phase 4 · terminated
- NCT04205877 — The U.S. PDA Registry · not yet recruiting
- NCT04222101 — Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy · NA · terminated
- NCT03897335 — Preventing Acute Kidney Injury (AKI) in Pediatric Patients · Phase 3 · unknown
- NCT03860012 — Folic Acid in Pediatric Inflammatory Bowel Disease · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03163394 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Le Bonheur Children's Hospital
- Last refreshed: 27 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03163394.
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