Chronic Kidney Disease Clinical Trial
— PREDICTOfficial title:
Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract
Verified date | September 2023 |
Source | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 292 |
Est. completion date | January 2025 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 4 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Pediatric Nephrology Dialysis and Transplant Unit IRCCS Ca'Granda | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | IL Sogno di Stefano, Ministero della Salute, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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