Assessment of the Efficacy on the 5th Day of Antibiotic Therapy for Febrile Urinary Tract Infections Among Children From 3 Months to 18 Years Old

Study Overview
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Brief Summary
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The main objective is to describe the rate of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection in children between 3 months and 18 years of age.

Detailed Description
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This is a non-randomised prospective monocentric pilot study whose main objective is to describe the proportion of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection, in children between 3 months and 18 years of age. After being informed about the study, all patient meeting inclusion criteria will respond to a survey at D2, D5, D10 and D28 to evaluate the persistence of symptoms to determine the effectiveness of a 5-day course of antibiotic treatment. All patients will be treated in accordance to the French guidelines.

Official Title
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Assessment of the Efficacy on the 5th Day of Antibiotic Therapy for Febrile Urinary Tract Infections Among Children From 3 Months to 18 Years Old

Conditions
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Urinary Tract Infections, Pediatric Disorder

Intervention / Treatment
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* Other: Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child between 3 months and 18 years old Diagnosis of uncomplicated febrile urinary tract infection certain and defined by : Naked fever (without an identifiable source of infection) for at least 24 hours for boys and 48 hours for girls. A urine test strip with at least 2 crosses of leukocyturia ≥ or 1 cross of leukocyturia ≥ with positive nitrituria A cytobacteriological urine test with leukocyturia greater than 10/mm3 in the case of catheterisation or Clean catch or greater than 100/mm3 if the collection is performed by bag (Urinocol®). Positive bacteriological urine culture Response to antibiotic therapy Absence of other diagnoses that could explain the clinical picture Exclusion Criteria: Children under 3 months old Immunodepression Underlying uropathy or known neurological bladder disease

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient having urinary tract infection<br>Patients with a confirmed urinary tract infection in accordance with the GPIP (french Pediatric Infectious Disease Group) definition and inclusion criteria. | Other: Survey<br>* Patients or their parents will complete a survey at D2, D5, D10 and D28 to assess the presence or absence of a symptom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of treatment | The main evaluation criteria aims to determine the effectiveness of a 5-day course of antibiotic treatment. Treatment failure is characterised by the presence at Day 5 of clinical signs (abdominal pain, urinary functional signs, urinary burns) and/or a fever ≥ at 38°C and/or a new positive cytobacteriological urine test performed after antibiotic therapy due to the persistence and/or reappearance of symptoms. | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte count | Leukocyte count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic. | Day 1 | 
| Mode of sampling | Leukocyturia rate (cell per mm3), according to the method of collection, on the sample carried out at the first consultation of children with febrile urinary tract infections at diagnostic. | Day 1 | 
| Rate of failure | Measurement of the number of patients presenting a failure at Day 10 or a relapse at 28 days of treatment of a febrile urinary infection. This is characterised by the presence or reappearance of symptoms suggestive of a febrile urinary infection and/or fever without any other possible diagnosis and a positive cytobacteriological urine test with a phenotypically identical micro-organism on the new antibiogram | Day 28 | 
| Procalcitonin levels | Procalcitonin levels (in µg/L) in children with uncomplicated febrile urinary tract infections at diagnostic. | Day 1 | 
| CRP levels | C Reactive Protein (CRP) levels (in mg/l) in children with uncomplicated febrile urinary tract infections at diagnostic. | Day 1 | 
| Polynuclear cell count | Blood polynuclear cell count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic. | Day 1 |