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

Medical University of Warsaw221 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

221

Conditions

Urinary Tract Infections in Children

Interventions

Longer therapy durationOTHER

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).

Shorter therapy durationOTHER

Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (2)

Children's Hospital for The Medical University of Warsaw

Warsaw, Poland

RECRUITING

The Holy Family Specialistic Hospital

Warsaw, Poland

RECRUITING

Outcomes

Primary Outcomes

frequencies of recurrence of UTI

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.

Time frame: 3 months after intervention

Secondary Outcomes

frequencies of reinfection of UTI

The reinfection of a UTI is diagnosed when the next infection is caused by a different bacteria.

Time frame: 6 months after intervention

antibiotic-associated diarrhoea (AAD), compliance

AAD is defined by the daily production of at least 3 loose or watery stools for at least 48 hours during antibiotic treatment and 7 days after administration of the antibiotic. Compliance with the study protocol will be assessed by direct interview with the patient and/or caregiver and by measuring the amount of the fluid left in the bottle at the end of the intervention.

Time frame: 7 days after intervention

Central Contacts

Maria Daniel, MD

CONTACT

+48696477117 maria.daniel@wum.edu.pl

Data from ClinicalTrials.gov

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