Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract

Summary

The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage.

Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.

Conditions

• Vesicoureteral Reflux
• Renal Hypodysplasia, Nonsyndromic, 1
• Chronic Kidney Disease

Interventions

DRUG

nitrofurantoin

antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)

OTHER

No prophylaxis

children will be followed, but no antibiotic prophylaxis will be administered

DRUG

Amoxicillin-Potassium Clavulanate Combination

antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)

DRUG

Trimethoprim/sulfamethoxazole

antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)

DRUG

Cefixime

antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)

Sponsors & Collaborators

• Ministero della Salute, Italy

  collaborator OTHER

• IL Sogno di Stefano

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  lead OTHER

Principal Investigators

• Giovanni Montini, MD · Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan

• Franz Schaefer, Professor · Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, Germany

• Otto Mehls, Professor · Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, Germany

• Lutz T. Weber, Professor · Ärztlicher Leiter der Kindernephrologie Klinik und Poliklinik für Kinder- und Jugendmedizin Uniklinik Köln - Köln

• Aleksandra M Zurowska, Professor · Medical University of Gdansk, Department Paediatric & Adolescent Nephrology & Hypertension - Gdansk - Poland

• Fatos Yalcinkaya, Professor · Department of Pediatric Nephrology, School of Medicine, Ankara University, Ankara, Turkey

• Esra Baskin, Professor · Paediatric Nephrology Division, Department of Paediatrics, Faculty of Medicine, Baskent University, Ankara, Turkey

• Enrico Verrina, MD · UOC Nefrologia, Dialisi e Trapianto, IRCCS Giannina Gaslini, Genova, Italy

• William Morello, MD · Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan

• Piotr Czarniak, MD · Department of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk, Gdansk - Poland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

4 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2020-01-31

Completion

2025-01-31

Countries

• Italy

Study Locations