Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156546
Status:
UNKNOWN
Last Update Posted:
2005-12-01
First Post:
2005-09-07
Brief Title:
Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a Previous Urinary Tract Infection
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a History of Upper Urinary Tract Infectionsa Multicentre Randomised Study
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of infection and the risk of appearance of kidney scars in children with a documented previous upper UTI
Detailed Description:
Background
Upper urinary tract infections UTI are common in children especially when functional and anatomical abnormalities of the urinary tract co-exist such as vesico-ureteral reflux VUR urinary tract obstruction uropathy and bladder dysfunction They are associated with the risk of long-term complications including permanent renal damage renal scarring which occurs in 15 of cases The objective of the diagnosis and medical treatment of UTI in children is the prevention of such complications Medical treatment includes long-term antimicrobial prophylaxis to be continued for periods ranging from 6 months to 2 years Recent studies have revealed the emergence of therapy-induced resistance A review of the literature has highlighted the lack of properly designed large clinical trials demonstrating the efficacy of long-term low-dose antimicrobial prophylaxis in terms of reduction in UTI recurrence
Methods and design
The study is a controlled randomised open-label 3-armed parallel-group clinical trial comparing no prophylaxis group 1 with prophylaxis with co-trimoxazole 15 mgkg daily group 2 and with amoxicillin clavulanic acid 15 mgkg daily group 3 for 12 months
Assuming that the incidence of recurrences is 20 defining efficacy as an incidence of 10 per group and setting error 005 and power 90 220 patients per group ie a total of 660 patients are required The study population will consist of children aged between 2 months and 6 years with normal renal function creatinine clearance 70 mlmin173m2 and a first episode of documented UTI who presents at least one of the following an acute pyelonephritic lesion at the DMSA scan andor a VUR at the baseline micturating cystography
Patients will be followed-up for 12 months Urinalysis and urine cultures will be performed every month and clinical examinations after 6 and 12 months both will be performed whenever UTI is suspected Sonography Doppler sonography optional and DMSA scintigraphy will be performed at baseline and at the end of the study
Upper urinary tract infections UTI are common in children especially when functional and anatomical abnormalities of the urinary tract co-exist such as vesico-ureteral reflux VUR urinary tract obstruction uropathy and bladder dysfunction They are associated with the risk of long-term complications including permanent renal damage renal scarring which occurs in 15 of cases The objective of the diagnosis and medical treatment of UTI in children is the prevention of such complications Medical treatment includes long-term antimicrobial prophylaxis to be continued for periods ranging from 6 months to 2 years Recent studies have revealed the emergence of therapy-induced resistance A review of the literature has highlighted the lack of properly designed large clinical trials demonstrating the efficacy of long-term low-dose antimicrobial prophylaxis in terms of reduction in UTI recurrence
Methods and design
The study is a controlled randomised open-label 3-armed parallel-group clinical trial comparing no prophylaxis group 1 with prophylaxis with co-trimoxazole 15 mgkg daily group 2 and with amoxicillin clavulanic acid 15 mgkg daily group 3 for 12 months
Assuming that the incidence of recurrences is 20 defining efficacy as an incidence of 10 per group and setting error 005 and power 90 220 patients per group ie a total of 660 patients are required The study population will consist of children aged between 2 months and 6 years with normal renal function creatinine clearance 70 mlmin173m2 and a first episode of documented UTI who presents at least one of the following an acute pyelonephritic lesion at the DMSA scan andor a VUR at the baseline micturating cystography
Patients will be followed-up for 12 months Urinalysis and urine cultures will be performed every month and clinical examinations after 6 and 12 months both will be performed whenever UTI is suspected Sonography Doppler sonography optional and DMSA scintigraphy will be performed at baseline and at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None