Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161330
Status:
TERMINATED
Last Update Posted:
2020-12-14
First Post:
2005-09-08
Brief Title:
Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children a RCT
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial of Antibiotic Treatment in Children With Urinary Tract Infections Oral AmoxicillinClavulanic Acid vs Initial iv Ceftriaxone
Status:
TERMINATED
Status Verified Date:
2004-07
Last Known Status:
None
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:
The main objectives of the study are
1 to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
2 to assess the diagnostic power of the various imaging technique renal ultrasonogram voiding cystourethrogram and renal scanning with technetium-99m-labeled dimercaptosuccinic acid
1 to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
2 to assess the diagnostic power of the various imaging technique renal ultrasonogram voiding cystourethrogram and renal scanning with technetium-99m-labeled dimercaptosuccinic acid
Detailed Description:
Background Upper urinary tract infections UTIs are common in children but attitudes toward the diagnosis and the acute treatment are heterogeneous among pediatricians and pediatric nephrologists In effect the choice of antibiotic regimens is largely empirical and based on local practice with no rationale for the choice of oral or parenteral administration A retrospective study 1993-97 showed that in 1333 36 M hospitalized children because of a prove UTI parenteral antibiotic was given initially to 756 572 of the population studied
We are aware of a unique randomized clinical trial which has shown no differences in the short term mean time to defervescence and long term outcomes symptomatic reinfections and renal scarring of children receiving oral cefixime for 14 days versus vs initial iv cefotaxime for 3 days followed by oral cefixime for 11 days
The management of patients with UTI consists not only in antibiotic treatment of acute episodes but also in the global evaluation of any risk factors Current recommendations for imaging of the urinary tract are not based on prospective studies of outcomes development of renal scars A recent publication Hoberman et al suggests that renal ultrasonography and DMSA scanning at the time of acute illness are of limited value and recommends the routine use of voiding cystourethrography to identify children with reflux
Aims
Main objective of the study is
1 to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
Secondary objectives of the study are
1 to assess the diagnostic power of the various imaging technique renal ultrasonogram voiding cystourethrogram and renal scanning with technetium-99m-labeled dimercaptosuccinic acid
2 to evaluate a possible role of genetic polymorphisms implicated in the evolution of kidney damage
3 to obtain area based protocols for the treatment and hospitalization of children with UTI
Study design A randomised controlled open-label 2-armed parallel-group study comparing the safety and efficacy of oral antibiotic 10 days of amoxicillin clavulanic acid 50 mgKgday vs initial iv treatment ceftriaxon 50 mgKgday until defervescence followed by oral treatment amoxicillin clavulanic acid for a total of 10 days in children with a first episode of UTI
Criteria for the diagnosis of upper UTI upon entry
1 Urinalysis two concordant consecutive tests
Urine WBC higher 25ul 1 with dipstick
2 Urine culture two concordant consecutive tests
Growth of only one microorganism 100000 CFU
3 Fever higher than 38C NB in the first 6 months of life fever is not an essential criterion
4 Inflammation indices in the first 48 hours ESR higher than 30 andor C-reactive Protein more than 3 times the upper limit of normal values
5 Neutrophils higher than the normal values for age
The diagnosis of upper UTI is made by presence of criteria 1 2 and at least two of the others
Assuming that 15 of children with pyelonephritis and treated iv will develop renal scars at the 12 month DMSA defining efficacy as an incidence of 10 per group and setting alfa error 005 and power 80 220 patients per group ie a total of 440 patients are required
The computer generated randomization list is stratified for hospital sex and age o than 2 years and based on variable blocks of 10 or more
Primary end points are1 Duration of fever 38 2 Sterilization of the urine 3 Reduction of the blood inflammatory indices 4 Incidence of renal scarring documented at 12 month
The imaging diagnostic work-up is as follow sonography US of the kidney and the bladder and DMSA renal scintigraphy within 10 days from onset of antibiotic treatment and at the end of the study 12 months voiding cystourethrography VC 1-2 months after UTI
We are aware of a unique randomized clinical trial which has shown no differences in the short term mean time to defervescence and long term outcomes symptomatic reinfections and renal scarring of children receiving oral cefixime for 14 days versus vs initial iv cefotaxime for 3 days followed by oral cefixime for 11 days
The management of patients with UTI consists not only in antibiotic treatment of acute episodes but also in the global evaluation of any risk factors Current recommendations for imaging of the urinary tract are not based on prospective studies of outcomes development of renal scars A recent publication Hoberman et al suggests that renal ultrasonography and DMSA scanning at the time of acute illness are of limited value and recommends the routine use of voiding cystourethrography to identify children with reflux
Aims
Main objective of the study is
1 to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
Secondary objectives of the study are
1 to assess the diagnostic power of the various imaging technique renal ultrasonogram voiding cystourethrogram and renal scanning with technetium-99m-labeled dimercaptosuccinic acid
2 to evaluate a possible role of genetic polymorphisms implicated in the evolution of kidney damage
3 to obtain area based protocols for the treatment and hospitalization of children with UTI
Study design A randomised controlled open-label 2-armed parallel-group study comparing the safety and efficacy of oral antibiotic 10 days of amoxicillin clavulanic acid 50 mgKgday vs initial iv treatment ceftriaxon 50 mgKgday until defervescence followed by oral treatment amoxicillin clavulanic acid for a total of 10 days in children with a first episode of UTI
Criteria for the diagnosis of upper UTI upon entry
1 Urinalysis two concordant consecutive tests
Urine WBC higher 25ul 1 with dipstick
2 Urine culture two concordant consecutive tests
Growth of only one microorganism 100000 CFU
3 Fever higher than 38C NB in the first 6 months of life fever is not an essential criterion
4 Inflammation indices in the first 48 hours ESR higher than 30 andor C-reactive Protein more than 3 times the upper limit of normal values
5 Neutrophils higher than the normal values for age
The diagnosis of upper UTI is made by presence of criteria 1 2 and at least two of the others
Assuming that 15 of children with pyelonephritis and treated iv will develop renal scars at the 12 month DMSA defining efficacy as an incidence of 10 per group and setting alfa error 005 and power 80 220 patients per group ie a total of 440 patients are required
The computer generated randomization list is stratified for hospital sex and age o than 2 years and based on variable blocks of 10 or more
Primary end points are1 Duration of fever 38 2 Sterilization of the urine 3 Reduction of the blood inflammatory indices 4 Incidence of renal scarring documented at 12 month
The imaging diagnostic work-up is as follow sonography US of the kidney and the bladder and DMSA renal scintigraphy within 10 days from onset of antibiotic treatment and at the end of the study 12 months voiding cystourethrography VC 1-2 months after UTI
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