7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children

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.

Inclusion Criteria (must have all):

• children aged from 3 months to 7 years
• clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment >10 in the field of view);
• fever ≥38°C
• positive urine collection with sensitivity for cefuroxime
• treatment cefuroxime or cefuroxime axetil for 7 days

Exclusion Criteria (must have one):

• history of a UTI in the last 3 months
• prophylaxis for UTI
• antibiotic therapy in the last month
• known allergy to the study drugs
• immunosuppression therapy
• disease with immune deficiency
• children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
• severe obstructive uropathy