Infants with vesicoureteral reflux grade III-V, started before the first symptomatic infection. MedDRA version: 21.1 Level: LLT Classification code 10047371 Term: Vesicoureteral reflux System Organ Class: 100000004857
Conditions
Interventions
Product Name: Amoxicilline + clavulanic acid
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Age between 1 and 4 months b. Gestational age > 35 weeks c. Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2 at three months of age d. No previous symptomatic UTI e. Imaging Diagnostic work-up completed and presence of grade III to V vesico-ureteral reflux f. Informed consent of parents g. No urethal valves Are the trial subjects under 18? yes Number of subjects for this age range: 290 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Age 4 months b. Gestational age < 35 weeks c. Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age d. Patients with neurogenic bladder, myelomeningocele, uretero-pelvic junction and/or uretero-vescico junction obstruction, or other malformations leading to potential voiding disturbances, apart from urethral valves e. Patients with no or low grade reflux (grade I and II). f. Hypersensitivity to the all the utilized antimicrobial agent g. Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort. h. Use of experimental drugs in the month previous to the beginning of the study i. Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent. j. Presence of urethral valves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the evaluation of the effectiveness of antimicrobial prophylaxis in the reduction of symptomatic UTIs in infants with vesicoureteral reflux grade III-V, started before the first symptomatic infection. ;Secondary Objective: The secondary objectives are the evaluation of: 1. the role of symptomatic and febrile UTIs on the appearance and progression of kidney damage and development of renal function; 2. the natural history of renal function of paediatric patients with congenital kidney or urinary tract anomalies during the first 5 years of life; 3. the number of new renal scars at the 2 and 5-year follow-up DMSA scan; 4. the natural evolution of vesico-ureteral reflux during the first 5 years of life and its correlation with UTIs, renal scars and impairment of renal function; 5. the hypothetical role of prophylactic antibiotic therapy during the first months of life on BMI at 2 and 5 years of age 6. the modification in gut microbiota induced by continuous antibiotic exposure during the first months of life.;Primary end point(s): The primary end point is the rate of first symptomatic urinary tract infections during the 24-month observation period. ;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are: 1. febrile UTIs; 2. number of new renal scars at the 2 and 5-year follow-up DMSA scan; 3. development of renal function, hypertension and/or proteinuria, anatomical growth of the kidneys at 2 and 5.year follow-up; 4. evaluation of the natural course of renal function for hypo-dysplastic kidneys during the first 5 years of life; 5. evaluation of BMI at 2 and 5 years of age; 6. modification in gut microbiota induced by continuous antibiotic exposure during the first months of life.;Timepoint(s) of evaluation of this end point: 60 months | — |
Countries
Australia, Belgium, Germany, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Turkey
Contacts
Public ContactUOC Nefrologia, Dialisi e Trapianto
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
Outcome results
None listed