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NCT05814250
Ultrasonography in Children With First Febrile Urinary Tract Infection
trial in Urinary Tract Infections in 20 participants. Currently enrolling.
31 March 2025
Quick facts
| Lead sponsor | IRCCS Burlo Garofolo |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 13 June 2022 |
| Primary completion | 31 March 2025 |
| Estimated completion | 31 March 2028 |
| Sites | 3 locations across Italy |
Conditions studied
- Urinary Tract Infections — all drugs for Urinary Tract Infections →
Sponsor
IRCCS Burlo Garofolo — full company profile →
Who can join
Adults 2 Months to 3, any sex, with Urinary Tract Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In recent decades, different tests have been recommended by guidelines in the management of first febrile urinary tract infection (fUTI) in children, including kidney ultrasound (KUS), cystography (VCUG) and renal scintigraphy in order to exclude underlying kidney anomalies. The majority of guidelines, continue to recommend a routine KUS for all children at the first fUTI. On the other hand, as this approach is not based on robust evidence, other guidelines suggest that KUS should only be performed on selected patients according to specific risks. Despite being a non-invasive and radiation-free method, KUS tests negative in 83% of cases of fUTIs and possesses low specificity for low grade vesico-ureteral reflux (VUR). Since VUR is the most commonly associated renal malformation with UTI, it is evident that all the guidelines focus on the research of VUR, especially in times when antenatal ultrasound allows to screen for major congenital anomalies of kidney and urinary tract (CAKUT). However, VUR-associated nephropathy appears to be related to primary dysplastic damage rather than to be secondary to the reflux itself and not preventable from antibiotic prophylaxis in terms of recurrence and of kidney scar. To reduce the number of normal VCUGs performed, recent evidence regarding VUR suggests that the presence of pathogens different from E. coli and UTI recurrence may help to identify children who necessitate further investigations. A preliminary retrospective monocentric study enrolling all patients aged 2 to 36 months diagnosed with first fUTI who subsequently underwent US evaluation of the kidneys and urinary tract, found that atypical germ and recurrence of UTI exhibits a 85% sensitivity to detect pathological ultrasound. The aim of this multicentric study is to prospectively evaluate the diagnostic accuracy of the presence of atypical germ combined with the recurrence of UTI in predicting the positivity of KUS in children aged 2 months to 3 years old with first episode of fUTI
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05814250
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- ASCO Meeting Library
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Related trials
Other recruiting trials for Urinary Tract Infections
Currently open trials in the same condition.
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- NCT07186465 — Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis · Phase 4 · recruiting
- NCT07207291 — Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers · Phase 1 · recruiting
- NCT06715306 — Intravenous Versus Oral Treatment of the Main Acute Infections · NA · recruiting
Other IRCCS Burlo Garofolo trials
Trials by the same sponsor.
- NCT06895278 — Articular Damage in Patients With Juvenile Idiopathic Arthritis After Transition to Adult Care · not yet recruiting
- NCT05821569 — Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding · unknown
- NCT06310421 — Spinal Muscular Atrophy Neonatal Screening Program · recruiting
- NCT05806372 — Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy · unknown
- NCT06324578 — Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease · 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 NCT05814250 (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 IRCCS Burlo Garofolo
- Last refreshed: 12 June 2024
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/NCT05814250.
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