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 (PEDIU5)

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infections; Pediatric Disorder
• Intervention / Treatment: Other: Survey

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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Patient having urinary tract infection; Patients with a confirmed urinary tract infection in accordance with the GPIP (french Pediatric Infectious Disease Group) definition and inclusion criteria.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (ACTUAL): December 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 2020/530

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No