Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04400110
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2020-05-19
Brief Title:
Short Therapy for Febrile UTI in Childhood
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Shortened Antibiotic Therapy for Febrile Urinary Tract Infection UTI in Childhood a Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-03
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:
Febrile urinary tract infections UTIs are common in children but there is no consensus concerning the duration of the antibiotic treatment Current recommendations include the use of an oral antibiotic chosen between amoxicillin and clavulanic acid or a third-generation cephalosporin ceftibuten for a minimum of seven to a maximum of 14 days In an antibiotic overuse-sparing model proper evaluation of a shorter therapy in the treatment of febrile UTI in childhood is lacking
The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children
The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance
The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children
The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None