Research Project

Project Title:

PREDICT – Antibiotic Prophylaxis and Renal Damage in Congenital Abnormalities of the Kidney and Urinary Tract

Project Type:

Clinical Trial, Enrolment ongoing
Adjunct biobank: DNA, Serum, Urine

Disease group(s):

Congenital Malformations & Ciliopathies

Project 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.

Lead principal investigator(s):

Giovanni Montini, Milano

Co-investigator(s):

Franz Schaefer, Heidelberg
Lutz Weber, Cologne
Aleksandra Zurowska, Gdansk
Carmine Pecoraro, Naples
Luisa Murer, Padova
Francesco Emma, Rome
Augustina Jankauskiene, Vilnius

Project Period:

12/2013   -   12/2022

Sponsors:

Non-profit foundation, National funding agency

Project web page:

predicttrial.cineca.it

ClinicalTrials.gov:

NCT02021006

EudraCT Nr.:

2013-000309-21

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