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

NCT04667546 | Unknown

• 1 other identifier: 2020/530
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infections; Pediatric Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Leukocyte count

  Day 1

• Mode of sampling

  Day 1

• Rate of failure

  Day 28

• Procalcitonin levels

  Day 1

• CRP levels

  Day 1

Study Arms (1)

Patient having urinary tract infection

OTHER

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

Other: Survey

Interventions

Survey OTHER

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

Patient having urinary tract infection

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Children under 3 months old
• Immunodepression
• Underlying uropathy or known neurological bladder disease

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Raphael ANXIONNAT, MD

CONTACT

0033381218516; ranxionnat@chu-besancon.fr

Yacine ZEGGAY, Int

CONTACT

azeggay@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 14, 2020
• Study Start: December 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 14, 2020

Record last verified: 2020-12