Status:
UNKNOWN
Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a Previous Urinary Tract Infection
Lead Sponsor:
University of Padova
Collaborating Sponsors:
Regione Veneto
IL Sogno di Stefano
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
2-6 years
Phase:
PHASE4
Brief Summary
Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of infection and the risk of appearance of kidney scars in children with a documented previous upper UTI.
Detailed Description
Background Upper urinary tract infections (UTI) are common in children, especially when functional and anatomical abnormalities of the urinary tract co-exist, such as vesico-ureteral reflux (VUR), ur...
Eligibility Criteria
Inclusion
- Age between 2 months and 6 years
- Creatinine clearance (calculated according to Schwartz) 70 ml/min/1.73 m2 (for children in their first year of life, serum creatinine levels within normal range for age and sex)
- First documented upper UTI (diagnostic criteria in Table 1)
- Imaging Diagnostic work-up completed (Table 2) with at least the presence of an acute lesion at the DMSA scan and or a primary non severe reflux ( 1st or 3rd degree)
- Informed consent of parents
Exclusion
- Patients with chronic renal insufficiency or 30% relative function of one kidney at DMSA scan
- Patients with urinary tract disorders, such as vesico-ureteral reflux due to complex malformations of the urinary tract, obstruction of the posterior urethra, ureterocele or single kidney, neurogenic bladder
- Patients with reflux 4th degree
- Patients with pyelonephritis that developed during prophylaxis instituted because of prenatal diagnosis of urinary tract dilatation Hypersensitivity to one of the two selected antimicrobial agents
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00156546
Start Date
May 1 2000
End Date
July 1 2006
Last Update
December 1 2005
Active Locations (16)
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1
Pediatric Unit, Ospedale di Belluno
Belluno, Belluno, Italy
2
Pediatric Unit, Ospedale di Bentivoglio
Bentivoglio, Bologna, Italy
3
- Pediatric Department, Ospedale di Bolzano
Bolzano, Bolzano, Italy
4
Pediatric Unit, Ospedale di Cuneo
Cuneo, Cuneo, Italy