PEDIU5: 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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04667546

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections Pediatric Disorder	Other: Survey	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Leukocyte count [Day 1]
Leukocyte count (in cell per mm3) in children with uncomplicated febrile urinary tract infections at diagnostic.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT04667546

Other Study ID Numbers:

2020/530

First Posted:

Dec 14, 2020

Last Update Posted:

Dec 14, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Urinary Tract Infections

Study Results

No Results Posted as of Dec 14, 2020