A Phase 3 interventional study of nitrofurantoin and No prophylaxis in Vesicoureteral Reflux, Renal Hypodysplasia, Nonsyndromic, 1 and Chronic Kidney Disease, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Active, not recruiting at 1 site in Italy. Open to participants aged 1 Month to 4 Months. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Phase 3, Interventional, and Prevention
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.
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.
The study is comprised of:
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 292 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children 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)
Drug: nitrofurantoin · Drug: Amoxicillin-Potassium Clavulanate Combination · Drug: Trimethoprim/sulfamethoxazole · Drug: Cefixime
Children in this arm will not take antibiotic prophylaxis. Patients in this arm will do clinical/instrumental follow-up for 5 years
Other: No prophylaxis
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)
Also known as: Furadantin
children will be followed, but no antibiotic prophylaxis will be administered
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)
Also known as: amoxicilline/clavulanic acid, augmentin, clavulin
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)
Also known as: bactrim
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)
Also known as: cefixoral
urinary tract infections rate
Urinary tract infections will be strictly monitored in all enrolled patients (both group A and group B). The rate of urinary tract infections in the first 24 months from the enrolment will be compared between 2 groups
Time frame: during the first 24 months from enrolment
febrile urinary tract infections
Febrile urinary tract infections will be strictly monitored in all enrolled patients (both group A and group B). The rate of febrile urinary tract infections in the first 24 months from the enrolment will be compared between 2 groups
Time frame: during the first 24 months from enrolment
renal scars
the appearance of renal scars in a dimercaptosuccinic acid (DMSA) scan will be detected at 2 and 5 years from enrolment and compared between the 2 groups.
Time frame: at 2 years and 5 years from enrolment
serum creatinine (renal function)
The renal function (serum creatinine) will be monitored for all enrolled patients to explore the appearance and progression of renal damage
Time frame: at the enrolment,1 year, 2 years, 3 years, 4 years, 5 years
hypertension
the appearance of hypertension will be monitored at every visit in all enrolled children
Time frame: at 4, 8, 12, 18, 24, 36, 48, 60 months from enrolment
proteinuria
the appearance of proteinuria will be monitored at every visit in all enrolled children
Time frame: at 4, 8, 12, 18, 24, 36, 48, 60 months from enrolment
body mass index
body mass index will be evaluated at 2 and 5 years of follow-up and it will be correlated to the use of antibiotic prophylaxis
Time frame: at 2 and 5 years from enrolment
serum cystatin C (renal function)
The renal function (serum cystatin-C) will be monitored for all enrolled patients to explore the appearance and progression of renal damage
Time frame: at the enrolment,1 year, 2 years, 3 years, 4 years, 5 years
modification in gut microbiota induced by continuous antibiotic exposure during the first months of life
A stool sample will be collected, frozen and stored for gut microbiota and resistome profile analysis
Time frame: at the enrollment, 4 months, 8 months, 12 months, 2 years, 3 years, 4 years, 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico