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Clinical Trial Details

Trial ID: L1270
Source ID: NCT02021006
Associated Drug: Nitrofurantoin
Title: Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract
Acronym: PREDICT
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Vesicoureteral Reflux|Renal Hypodysplasia, Nonsyndromic, 1|Chronic Kidney Disease
Interventions: DRUG: nitrofurantoin|OTHER: No prophylaxis|DRUG: Amoxicillin-Potassium Clavulanate Combination|DRUG: Trimethoprim/sulfamethoxazole|DRUG: Cefixime
Outcome Measures: Primary: 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, during the first 24 months from enrolment | Secondary: 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, 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., 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, 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, 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, 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, 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, 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, at the enrollment, 4 months, 8 months, 12 months, 2 years, 3 years, 4 years, 5 years
Sponsor/Collaborators: Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Collaborators: Ministero della Salute, Italy|IL Sogno di Stefano
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 292
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2013-12
Completion Date: 2025-01
Results First Posted:
Last Update Posted: 2023-09-28
Locations: Pediatric Nephrology Dialysis and Transplant Unit IRCCS Ca'Granda, Milan, 20122, Italy
URL: https://clinicaltrials.gov/show/NCT02021006