Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
436

Summary

Conditions
  • Chronic Kidney Disease
  • Renal Hypodysplasia, Nonsyndromic, 1
  • Vesicoureteral Reflux
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 14 years
Gender
Both males and females

Description

Bacterial urinary tract infections (UTI) are common in young children. The presence of fever is considered to be a marker of renal parenchymal involvement. Renal damage during the acute phase of infection may lead to scarring, yet the role that scarring plays in the appearance of chronic kidney fail...

Bacterial urinary tract infections (UTI) are common in young children. The presence of fever is considered to be a marker of renal parenchymal involvement. Renal damage during the acute phase of infection may lead to scarring, yet the role that scarring plays in the appearance of chronic kidney failure is unknown. It is also unclear what influence scars have on the natural course of kidney function, especially in children with renal hypodysplasia, with or without vesicoureteral reflux (VUR). Renal hypodysplasia is the most common cause for dialysis and transplantation in the pediatric population. Patients suffering from recurrent UTIs and VUR have often undergone corrective surgery. For many years, it was also thought necessary to prescribe long-term antibiotic prophylaxis to all children with VUR. These treatment strategies were based on the ideas and opinions of the experts, rather than on hard scientific evidence. As regards the prevention of recurrent UTIs and the subsequent development of renal scarring, a long-term international study on Reflux was not able to demonstrate that surgical correction is more effective than antibiotic prophylaxis. Very little data is available regarding the use of long-term antibiotic prophylaxis in children with high grade reflux with or without renal hypodysplasia. The use of antibiotics during the first few months of life has been associated with a significant increase in body mass index (BMI). Even though this effect is probably limited, it could have a significant impact on public health given the widespread use of antibiotics and due to the considerable increase in cases of pediatric and adult obesity seen over the last few years. In spite of the lack of evidence, the use of prophylaxis is largely routine practice in most centres. Therefore, a randomized study is necessary in order to evaluate whether prophylaxis reduces the risk of symptomatic infections and subsequent renal damage. To assess the role of prophylaxis in patient with high grade vesicoureteral reflux we will perform a multicentre, prospective, randomized, controlled, open-label, study. Patients enrolled will be randomized in two groups: Group A: no antibiotic prophylaxis. Group B: antibiotic prophylaxis for 24 months. The choice of which antibiotic to prescribe from the list below is left to the discretion of each investigator, on the basis of local antibiotic resistance patterns. nitrofurantoin 1.5-2 mg/kg per day amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicillin) cefixime 2 mg/kg per day trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim) The study is comprised of: Phase 1: Pre-randomization - screening tests to determine eligibility for the trial. Phase 2: Active treatment - this phase follows randomization and foresees 24 months of antibiotic prophylaxis for Group B and clinical surveillance for Group A. Phase 3: Follow-up - a further 36 months of clinical, laboratory and instrumental evaluation of renal function and the progression of renal damage for a total follow-up period of 5 years

Tracking Information

NCT #
NCT02021006
Collaborators
  • Ministero della Salute, Italy
  • IL Sogno di Stefano
Investigators
Study Chair: Giovanni Montini, MD Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Study Director: Franz Schaefer, Professor Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, Germany Principal Investigator: Otto Mehls, Professor Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, Germany Principal Investigator: Lutz T. Weber, Professor Ärztlicher Leiter der Kindernephrologie Klinik und Poliklinik für Kinder- und Jugendmedizin Uniklinik Köln - Köln Principal Investigator: Aleksandra M Zurowska, Professor Medical University of Gdansk, Department Paediatric & Adolescent Nephrology & Hypertension - Gdansk - Poland Principal Investigator: Fatos Yalcinkaya, Professor Department of Pediatric Nephrology, School of Medicine, Ankara University, Ankara, Turkey Principal Investigator: Esra Baskin, Professor Paediatric Nephrology Division, Department of Paediatrics, Faculty of Medicine, Baskent University, Ankara, Turkey Principal Investigator: Enrico Verrina, MD UOC Nefrologia, Dialisi e Trapianto, IRCCS Giannina Gaslini, Genova, Italy Principal Investigator: William Morello, MD Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Principal Investigator: Piotr Czarniak, MD Department of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk, Gdansk - Poland