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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

NCT ID: NCT04667546

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections Pediatric Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Survey

Intervention Type OTHER

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

Interventions

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Survey

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Raphael ANXIONNAT, MD

Role: CONTACT

Phone: 0033381218516

Email: [email protected]

Yacine ZEGGAY, Int

Role: CONTACT

Email: [email protected]

Other Identifiers

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2020/530

Identifier Type: -

Identifier Source: org_study_id