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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 (PEDIU5)

Primary Purpose

Urinary Tract Infections, Pediatric Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Survey
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Tract Infections

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patient having urinary tract infection

    Arm Description

    Patients with a confirmed urinary tract infection in accordance with the GPIP (french Pediatric Infectious Disease Group) definition and inclusion criteria.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Leukocyte count
    Leukocyte count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.
    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.
    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
    Procalcitonin levels
    Procalcitonin levels (in µg/L) in children with uncomplicated febrile urinary tract infections at diagnostic.
    CRP levels
    C Reactive Protein (CRP) levels (in mg/l) in children with uncomplicated febrile urinary tract infections at diagnostic.
    Polynuclear cell count
    Blood polynuclear cell count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.

    Full Information

    First Posted
    November 16, 2020
    Last Updated
    December 8, 2020
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04667546
    Brief 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
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infections, Pediatric Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient having urinary tract infection
    Arm Type
    Other
    Arm Description
    Patients with a confirmed urinary tract infection in accordance with the GPIP (french Pediatric Infectious Disease Group) definition and inclusion criteria.
    Intervention Type
    Other
    Intervention Name(s)
    Survey
    Intervention Description
    Patients or their parents will complete a survey at D2, D5, D10 and D28 to assess the presence or absence of a symptom
    Primary Outcome Measure Information:
    Title
    Effectiveness of treatment
    Description
    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 Outcome Measure Information:
    Title
    Leukocyte count
    Description
    Leukocyte count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.
    Time Frame
    Day 1
    Title
    Mode of sampling
    Description
    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
    Title
    Rate of failure
    Description
    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
    Title
    Procalcitonin levels
    Description
    Procalcitonin levels (in µg/L) in children with uncomplicated febrile urinary tract infections at diagnostic.
    Time Frame
    Day 1
    Title
    CRP levels
    Description
    C Reactive Protein (CRP) levels (in mg/l) in children with uncomplicated febrile urinary tract infections at diagnostic.
    Time Frame
    Day 1
    Title
    Polynuclear cell count
    Description
    Blood polynuclear cell count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Raphael ANXIONNAT, MD
    Phone
    0033381218516
    Email
    ranxionnat@chu-besancon.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yacine ZEGGAY, Int
    Email
    azeggay@chu-besancon.fr

    12. IPD Sharing Statement

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