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

Centre Hospitalier Universitaire de Besancon54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Urinary Tract Infections Pediatric Disorder

Interventions

SurveyOTHER

Patients or their parents will complete a survey at D2, D5, D10 and D28 to assess the presence or absence of a symptom

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day 5

Secondary Outcomes

Leukocyte count

Leukocyte count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.

Time frame: 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.

Time frame: 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

Time frame: Day 28

Procalcitonin levels

Procalcitonin levels (in µg/L) in children with uncomplicated febrile urinary tract infections at diagnostic.

Time frame: Day 1

CRP levels

C Reactive Protein (CRP) levels (in mg/l) in children with uncomplicated febrile urinary tract infections at diagnostic.

Central Contacts

Raphael ANXIONNAT, MD

CONTACT

0033381218516 ranxionnat@chu-besancon.fr

Yacine ZEGGAY, Int

CONTACT

azeggay@chu-besancon.fr

Data from ClinicalTrials.gov

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