URINARY TRACT INFECTION MedDRA version: 9.1 Level: SOC Classification code 10038359
Conditions
Interventions
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Amoxicillin and enzyme inhibitor
Concentration type: equal
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Cefaclor
Concentration t
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Children from birth to 6 years of age 2- APN 1 episode 3- UTI  2 episodes in males and  3 in females, with normal US 4- UTI  1 episode, with positive findings on US (i.e. any urinary tract dilation, thickening of the pelvis and/or ureteral walls) 5- 1st-4th degree primitive VUR. 6- 5th degree VUR (specific management) Are the trial subjects under 18? yes Number of subjects for this age range: 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: 1 - Any form of CAKUT. VUR is not considered an exclusion critierion. 2 - Any other major malformation and/or syndrome known to be associated renal hypospalsia/dysplasia 3 - Glomerular Filtration Rate (GFR) < 90% of normal range calculated (Schwartz formula)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the best management to reduce renal damage in patients with APN and UTI and to improve their quality of life.;Secondary Objective: To establish whether the reduction in APN/UTI episodes coincides with VUR resolution or not.;Primary end point(s): 1. Number of APN and UTI episodes 2. Number of new renal scars 3. Failure to thrive 4. Kidney size 5. Relative renal function 6. Bacteria in colture and resistance (number of bacteria, type, antibiotic essay) | — |
Countries
Italy
Outcome results
None listed