Ignite Creation Date:
2024-05-05 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00724256
Status:
TERMINATED
Last Update Posted:
2012-02-17
First Post:
2008-07-18
Brief Title:
Short-term Antibiotic Therapy for Pyelonephritis in Childhood
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Randomised Controlled Trial on Efficacy and Safety of Short Term Versus Long Term Antibiotic Therapy for Pyelonephritis in Childhood
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
other upcoming studies patients refusal of invasive follow up DMSA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STUTI
Brief Summary:
The purpose of this study is to evaluate the efficacy of oral ceftibuten for 7 days versus 10 days in acute pyelonephritis in children
The main hypothesis is that the ceftibuten for 7 days will be not inferior to ceftibuten 10 days in the rate of renal scarring at 6-12 months
The main hypothesis is that the ceftibuten for 7 days will be not inferior to ceftibuten 10 days in the rate of renal scarring at 6-12 months
Detailed Description:
Acute pyelonephritis is one of the most common serious bacterial infections in childhood particularly in young children with an estimated prevalence in febrile infants of 53 It has been considered an important risk factor for the development of renal scarring and renal insufficiency More recently the long term outcomes of pyelonephritis has ameliorated probably because of prompt diagnosis and therapy and the importance of urinary tract infection as a risk factor for renal insufficiency has been questioned
Nevertheless the optimal type and duration of antibiotic therapy for acute uncomplicated pyelonephritis in children is not established yet
There is a general agreement that children who are dehydrated unable to drink or in whom sepsis is possible should be admitted to hospital for intravenous antibiotic treatment
Outside this conditions evidence suggest that children with acute pyelonephritis can be treated effectively with cefixime ceftibuten or amoxycillinclavulanic acid given orally 1
A recently updated Cochrane review on antibiotic treatment for acute pyelonephritis in children identified twenty three studies 3407 children No significant differences were found in persistent renal damage at six to 12 months 824 children RR 080 95 CI 050 to 126 or in duration of fever 808 children WMD 205 95 CI -084 to 494 between oral antibiotic therapy 10 to 14 days and IV therapy 3 days followed by oral therapy 10 days Similarly no significant differences in persistent renal damage 3 studies 341 children RR 113 95 CI 086 to 149 were found between IV therapy 3 to 4 days followed by oral therapy and IV therapy for 7 to 14 days
Authors concluded that children with acute pyelonephritis can be treated effectively with oral antibiotics cefixime ceftibuten and amoxycillinclavulanic acid or with short courses 2 to 4 days of IV therapy followed by oral therapy
Oral treatment also is easier to use and does not require admission to hospital leading to reduced costs
Nevertheless the exact duration of oral therapy is not established Current guidelines recommend 7-14 days course of broad-spectrum antibiotics capable of reaching significant renal levels
The objective of our study is to evaluate if oral ceftibuten for 7 days is equally effective as oral ceftibuten for 10 days in acute pyelonephritis in children
This is a non-inferiority randomised controlled trial to determine whether a short term therapy with ceftibuten 7 days will be therapeutically similar to a long term therapy 10 days measuring as major outcome the prevalence of renal scars
Nevertheless the optimal type and duration of antibiotic therapy for acute uncomplicated pyelonephritis in children is not established yet
There is a general agreement that children who are dehydrated unable to drink or in whom sepsis is possible should be admitted to hospital for intravenous antibiotic treatment
Outside this conditions evidence suggest that children with acute pyelonephritis can be treated effectively with cefixime ceftibuten or amoxycillinclavulanic acid given orally 1
A recently updated Cochrane review on antibiotic treatment for acute pyelonephritis in children identified twenty three studies 3407 children No significant differences were found in persistent renal damage at six to 12 months 824 children RR 080 95 CI 050 to 126 or in duration of fever 808 children WMD 205 95 CI -084 to 494 between oral antibiotic therapy 10 to 14 days and IV therapy 3 days followed by oral therapy 10 days Similarly no significant differences in persistent renal damage 3 studies 341 children RR 113 95 CI 086 to 149 were found between IV therapy 3 to 4 days followed by oral therapy and IV therapy for 7 to 14 days
Authors concluded that children with acute pyelonephritis can be treated effectively with oral antibiotics cefixime ceftibuten and amoxycillinclavulanic acid or with short courses 2 to 4 days of IV therapy followed by oral therapy
Oral treatment also is easier to use and does not require admission to hospital leading to reduced costs
Nevertheless the exact duration of oral therapy is not established Current guidelines recommend 7-14 days course of broad-spectrum antibiotics capable of reaching significant renal levels
The objective of our study is to evaluate if oral ceftibuten for 7 days is equally effective as oral ceftibuten for 10 days in acute pyelonephritis in children
This is a non-inferiority randomised controlled trial to determine whether a short term therapy with ceftibuten 7 days will be therapeutically similar to a long term therapy 10 days measuring as major outcome the prevalence of renal scars
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