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

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.

• Longer therapy duration (Other): 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 duration (Other): Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.

Primary outcomes

• frequencies of recurrence of UTI [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 outcomes

• frequencies of reinfection of UTI [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 [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.

Sex: All, ages: 3 Months to 7 Years

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

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• Results publication: Daniel M, Szajewska H, Panczyk-Tomaszewska M. 7-day compared with 10-day antibiotic treatment for febrile urinary tract infections in children: protocol of a randomised controlled trial. BMJ Open. 2018 Mar 2;8(3):e019479. doi: 10.1136/bmjopen-2017-019479. PMID 29500209

• Malgorzata Pańczyk-Tomaszewska, Assistant Professor, Study chair, Medical Univeristy of Warsaw
• Maria Daniel, MD, Principal investigator, Medical Univeristy of Warsaw