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 infectionMedDRA version: 17.1Level: LLTClassification code 10047371Term: Vesicoureteral refluxSystem Organ Class: 100000004857Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2013-000309-21-ES
- 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
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: 20
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is the evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection.;Secondary Objective: The secondary objectives are the evaluation of <br>1. the role of symptomatic and febrile UTIs on the appearance and progression of kidney damage and development of renal function; <br>2. the natural history of renal function of paediatric patients with congenital kidney or urinary tract anomalies during the first 5 years of life; <br>3. the natural evolution of vesico-ureteral reflux during the first 5 years of life and its correlation with UTIs, renal scars and impairment of renal function;<br>4. the hypothetic role of prophylactic antibiotic therapy during the first months of life on BMI at 2 and 5 years of age.;Primary end point(s): Symptomatic urinary tract infection rate during the 24-month observation period.;Timepoint(s) of evaluation of this end point: 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Number of febrile UTIs and of new renal scars (DMSA scan) at the 2 and 5 years follow-up in relation to the development of renal function (creatinine and Cystatin C plasma values, eGFR), hypertension (blood pressure >95th%ile per age, sex and height) and/or proteinuria (protein/creatinine), anatomical growth (renal length) of the kidneys at 2 and 5 years follow-up, evaluation of the natural course of renal function for hypo-dysplastic kidneys during the first 5 years of life;Timepoint(s) of evaluation of this end point: 60 months