NCT03221504

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 3 Months – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections in Children

Interventions

Type	Name	Description
OTHER	Longer therapy duration	Patients will receive cefuroxime axetil orally. Treatment will involve the supply of cefuroxime axetil 30 mg/kg/d in two divided doses (in blinded bottles).
OTHER	Shorter therapy duration	Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-07-31
• Completion: 2020-01-31
• First posted: 2017-07-18
• Last updated: 2018-03-20

Locations

2 sites across 1 country: Poland