Antibiotic Prophylaxis and Renal Damage In Congenital abnormalities of the kidney and urinary Tract

Conditions: evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection
MedDRA version: 16.0Level: LLTClassification code 10047371Term: Vesicoureteral refluxSystem Organ Class: 100000004857
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2013-000309-21-IT

Lead Sponsor: AOU di Bologna, Policlinico S.Orsola-Malpighi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 436

Inclusion Criteria

a.Age between 1 and 4 months
b.Gestational age > 35 weeks
c.Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2 at three months of age
d.No previous symptomatic UTI
e.Imaging Diagnostic work-up completed and presence of grade III to V vesico-ureteral reflux
f.Informed consent of parents

Are the trial subjects under 18? yes
Number of subjects for this age range: 436
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a.Age <1 and >4 months
b.Gestational age < 35 weeks
c.Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age
d.Patients with neurogenic bladder, myelomeningocele, uretero-pelvic junction and/or uretero-vescico junction obstruction, or other malformations leading to potential voiding disturbances, apart from urethral valves
e.Patients with no or low grade reflux (grade I and II).
f.Hypersensitivity to the all the utilized antimicrobial agent
g.Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort.
h.Use of experimental drugs in the month previous to the beginning of the study
i.Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent.