Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborators: IL Sogno di Stefano; Ministero della Salute, Italy
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefixime; Clavulanic Acid; Clavulanic Acids; Nitrofurantoin; Sulfamethoxazole; Trimethoprim

Criteria

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.