Urinary Tract Infections in Children Clinical Trial
Official title:
7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial
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.
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.
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