Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract (NCT02021006) | Clinical Trial Compass
UnknownPhase 3
Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract
Italy292 participantsStarted 2013-12
Plain-language 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.
Who can participate
Age range
1 Month – 4 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 1 and 4 months (\> 4 weeks and \<20 weeks of post-natal age)
* 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.
* Presence of 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
urinary tract infections rate
Timeframe: during the first 24 months from enrolment
Trial details
NCT IDNCT02021006
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico