Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03221504
Status:
UNKNOWN
Last Update Posted:
2018-03-20
First Post:
2017-07-07
Brief Title:
7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
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:
The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections UTIs in children It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower risk of adverse events and better compliance
Detailed Description:
In previously published European and global guidelines there has been no consensus among experts regarding the duration of therapy for a febrile UTI Depending on the recommendation the duration of treatment should be between 7-14 days
221 patients aged 3 months to 7 years with febrile UTIs defined as a combination of fever and leukocyturia in urine sediment will be randomly assigned to receive a 7-day treatment arm 7 days of cefuroximecefuroxime axetil followed by 3 days of blinded placebo or a 10-day treatment arm 7 days of cefuroximecefuroxime axetil followed by 3 days of blinded cefuroxime axetil
The primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention The secondary outcome measures will be antibiotic-associated diarrhea and compliance
221 patients aged 3 months to 7 years with febrile UTIs defined as a combination of fever and leukocyturia in urine sediment will be randomly assigned to receive a 7-day treatment arm 7 days of cefuroximecefuroxime axetil followed by 3 days of blinded placebo or a 10-day treatment arm 7 days of cefuroximecefuroxime axetil followed by 3 days of blinded cefuroxime axetil
The primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention The secondary outcome measures will be antibiotic-associated diarrhea and compliance
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?:
False
Is an FDA AA801 Violation?:
None