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

Urinary Tract Infections Clinical Trial

— PEDIU5  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04667546
• Other study ID #: 2020/530
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: January 2022

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Raphael ANXIONNAT, MD
• Phone: 0033381218516
• Email: ranxionnat[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pediatric Disorder
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Leukocyte count	Leukocyte count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.	Day 1
Secondary	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
Secondary	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
Secondary	Procalcitonin levels	Procalcitonin levels (in µg/L) in children with uncomplicated febrile urinary tract infections at diagnostic.	Day 1
Secondary	CRP levels	C Reactive Protein (CRP) levels (in mg/l) in children with uncomplicated febrile urinary tract infections at diagnostic.	Day 1
Secondary	Polynuclear cell count	Blood polynuclear cell count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.	Day 1