Shortened antibiotic therapy in urinary tract infections in childhood

Phase 1

• Conditions: FEBRILE URINARY TRACT INFECTION; MedDRA version: 20.1Level: LLTClassification code 10000822Term: Acute kidney infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-001941-41-IT
• Lead Sponsor: IRCCS MATERNO INFANTILE BURLO GAROFOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

- age from 3 months to 5 years
- clinical diagnosis of febrile urinary tract infection, defined by fever > or = 38 °C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) in two consecutive urine samples collected by bladder catheterization or clan catch
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Complicated febrile urinary tract infection (septic appearance, repeated vomiting with the impossibility to take the antibiotic by mouth, moderate severe-dehydration with the need for intravenous antibiotic therapy)
- Presence of an inserted urinary catheter
- Immunodeficiency
- Hypersensitivity to the active substance or other beta-lactam antibiotics
- Any Antibiotic treatment received in the previous 15 days.
- Presence of other chronic, uncontrolled medical condition
- Neurological bladder
- Phenylketonuria or glucose-galactose malabsorption
- Intestinal malabsorption
- Need for hospitalization
- poor compliance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if a five days oral course of amoxicillin and calvulanic acid is non-inferior to the standard ten-day regimen in the treatment of febrile urinary tract infections in children;Secondary Objective: - to evaluate short-term clinical efficacy defined as the complete resolution of the signs and symptoms related to the infection at the end of the treatment whitout the need of additional or alternative antibiotic therapy<br>- to evaluate the presence of antibiotic-resistant or opportunistic strains in relapses;Primary end point(s): Rate of infection recurrence after the discontinuance of antibiotic therapy;Timepoint(s) of evaluation of this end point: 30 days after the end of the treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - short term clinical efficacy at the end of the treatment cycle, defined as the complete resolution of the signs and symptoms related to pyelonephritis during treatment, without the need for additional or alternative antibiotic therapy, evaluated at the first follow-up;; - occurrance of adverse events (nausea, diarrhea, headache); - the emergence of antibiotic resistance or opportunistic strains, defined as the presence of positive urine (nitrite and / or leukocyte esterase) and positive urine culture for a single type of bacterium, resistant to amoxicillin-clavulanic acid. It will be evaluated only in suspected relapses through the execution of urine and urine culture.;Timepoint(s) of evaluation of this end point: 5 days after the end of the treatment; 5 days after the end of the treatment; 30 days after the end of the treatment