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

Study Overview
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Brief Summary
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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
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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.

Official Title
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7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial

Conditions
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Urinary Tract Infections in Children

Intervention / Treatment
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* Other: Longer therapy duration
* Other: Shorter therapy duration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic therapy for 10 days<br>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). | Other: Longer therapy duration<br>* 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).<br>|
| Experimental: Antibiotic therapy for 7 days<br>After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle). | Other: Shorter therapy duration<br>* Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequencies of reinfection of UTI | The reinfection of a UTI is diagnosed when the next infection is caused by a different bacteria. | 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. | 7 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary tract infections, pyelonephritis, cefuroxime, children