Management of children following acute pyelonefritis or recurrent urinary tract infection episodes and prevention of renal scarring: a prospective randomised controlled clinical trial. - ND

• Conditions: MedDRA version: 9.1Level: SOCClassification code 10038359; RINARY TRACT INFECTION

• Registration Number: EUCTR2009-012696-97-IT
• Lead Sponsor: ISTITUTO GIANNINA GASLINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)