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)

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Urinary Tract Infections; Pediatric Disorder

Treatments: Other: Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT04667546

2020/530

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Patient having urinary tract infection

Other group

Description:

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

Treatment:

Other: Survey