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


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.

Full Title of Study: “7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 31, 2019

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.


  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Antibiotic therapy for 10 days
    • After 7 days of cefuroxime treatment (oral, intravenous or sequential), patients from day 8 to day 10 will continue to receive the antibiotic (in blinded bottle).
  • Experimental: Antibiotic therapy for 7 days
    • After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • frequencies of reinfection of UTI
    • Time Frame: 6 months after intervention
    • The reinfection of a UTI is diagnosed when the next infection is caused by a different bacteria.
  • antibiotic-associated diarrhoea (AAD), compliance
    • Time Frame: 7 days after intervention
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Warsaw
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Malgorzata Pańczyk-Tomaszewska, Assistant Professor, Study Chair, Medical Univeristy of Warsaw
    • Maria Daniel, MD, Principal Investigator, Medical Univeristy of Warsaw
  • Overall Contact(s)
    • Maria Daniel, MD, +48696477117, maria.daniel@wum.edu.pl


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Conway PH, Cnaan A, Zaoutis T, Henry BV, Grundmeier RW, Keren R. Recurrent urinary tract infections in children: risk factors and association with prophylactic antimicrobials. JAMA. 2007 Jul 11;298(2):179-86.

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Ammenti A, Cataldi L, Chimenz R, Fanos V, La Manna A, Marra G, Materassi M, Pecile P, Pennesi M, Pisanello L, Sica F, Toffolo A, Montini G; Italian Society of Pediatric Nephrology. Febrile urinary tract infections in young children: recommendations for the diagnosis, treatment and follow-up. Acta Paediatr. 2012 May;101(5):451-7. doi: 10.1111/j.1651-2227.2011.02549.x. Epub 2012 Jan 3.

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