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

Vesicoureteral Reflux research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Age between 1 and 4 months - Gestational age > 35 weeks - Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2 - No previous symptomatic UTI - Imaging Diagnostic work-up completed and presence of grade III to V vesicoureteral reflux - Informed consent of parents Exclusion Criteria: - Age <1 and >4 months - Gestational age < 35 weeks - Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age - Patients with neurogenic bladder, myelomeningocele, ureteropelvic junction and/or ureterovesical junction obstruction, or other malformations leading to potential voiding disturbances, apart from urethral valves - Patients with no or low grade reflux (grade I and II). - Hypersensitivity to the all the utilized antimicrobial agent - Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort. - Use of experimental drugs in the month previous to the beginning of the study - Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Vesicoureteral Reflux

Renal Hypodysplasia, Nonsyndromic, 1

Chronic Kidney Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:nitrofurantoinantibiotic 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 prophylaxischildren will be followed, but no antibiotic prophylaxis will be administered

Drug:Amoxicillin-Potassium Clavulanate Combinationantibiotic 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/sulfamethoxazoleantibiotic 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:Cefiximeantibiotic 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)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ANTIBIOTIC PROPHYLAXISChildren in this arm will take antibiotic prophylaxis for 2 years. Patients in this arm will do clinical/instrumental follow-up for 5 years. 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 Amoxicillin-Potassium Clavulanate Combination 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)

NO PROPHYLAXISChildren in this arm will not take antibiotic prophylaxis. Patients in this arm will do clinical/instrumental follow-up for 5 years

Study Status

Recruiting

Start Date: December 2013

Completed Date: December 2021

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: urinary tract infections rate

Secondary Outcome: febrile urinary tract infections

Study sponsors, principal investigator, and references

Principal Investigator: Giovanni Montini, MD

Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Collaborator: Ministero della Salute, Italy

More information:https://clinicaltrials.gov/show/NCT02021006

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