7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Tract Infections in Children
- Sponsor
- Medical University of Warsaw
- Enrollment
- 221
- Locations
- 2
- Primary Endpoint
- frequencies of recurrence of UTI
- Last Updated
- 8 years ago
Overview
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 cefuroxime/cefuroxime axetil followed by 3 days of blinded placebo) or a 10-day treatment arm (7 days of cefuroxime/cefuroxime 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
frequencies of recurrence of UTI
Time Frame: 3 months after intervention
New onset of symptomatic UTI within the 3 months follow-up period. The recurrence of a UTI is diagnosed when the next infection is caused by the same microorganism during 3 months following the treatment of a UTI.
Secondary Outcomes
- frequencies of reinfection of UTI(6 months after intervention)
- antibiotic-associated diarrhoea (AAD), compliance(7 days after intervention)