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: 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
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
- 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.
- 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
- Lead Sponsor
- Medical University of Warsaw
- Provider of Information About this Clinical Study
- 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, email@example.com
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