Pediatric Disorder, Urinary Tract Infections
Conditions
Brief summary
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
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.
Interventions
OTHERSurvey
Patients or their parents will complete a survey at D2, D5, D10 and D28 to assess the presence or absence of a symptom
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of treatment | Day 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of sampling | Day 1 | 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. |
| Rate of failure | Day 28 | 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 |
| Procalcitonin levels | Day 1 | Procalcitonin levels (in µg/L) in children with uncomplicated febrile urinary tract infections at diagnostic. |
| CRP levels | Day 1 | C Reactive Protein (CRP) levels (in mg/l) in children with uncomplicated febrile urinary tract infections at diagnostic. |
| Polynuclear cell count | Day 1 | Blood polynuclear cell count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic. |
| Leukocyte count | Day 1 | Leukocyte count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic. |
Contacts
Primary ContactRaphael ANXIONNAT, MD
Backup ContactYacine ZEGGAY, Int
Outcome results
None listed