Short Therapy for Febrile UTI in Childhood

Overview

Febrile urinary tract infections (UTIs) are common in children, but there is no consensus concerning the duration of the antibiotic treatment. Current recommendations include the use of an oral antibiotic, chosen between amoxicillin and clavulanic acid or a third-generation cephalosporin (ceftibuten), for a minimum of seven to a maximum of 14 days. In an antibiotic overuse-sparing model, proper evaluation of a shorter therapy in the treatment of febrile UTI in childhood is lacking.

The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children.

The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood, contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance.

Full Title of Study: “Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2023

Interventions

  • Drug: Amoxicillin and Clavulanic Acid in Oral Dose Form
    • 50 mg/kg three times daily administered orally

Arms, Groups and Cohorts

  • Experimental: Short treatment group
    • Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days
  • Active Comparator: Standard treatment group
    • amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days

Clinical Trial Outcome Measures

Primary Measures

  • Rate of infection recurrence
    • Time Frame: within 30 days after the end of the intervention
    • Infection recurrence rate is defined as the reappearance of signs and symptoms of febrile UTI by the first day after the end of antibiotic therapy

Secondary Measures

  • Rate of complete resolution of signs and symptoms
    • Time Frame: within 30 days after the end of the intervention
    • The complete resolution of the signs and symptoms (clinical assessment and urinalysis) related to the infection evaluated at the end of the treatment, without the need for additional or alternative antibiotic therapy (short term clinical efficacy)
  • Rate of antibiotic-resistant or of opportunistic strains in relapses
    • Time Frame: within 30 days after the end of the intervention
    • Antibiotic resistance is defined as the presence of positive urinalysis and positive urine culture for a single type of bacterium resistant to amoxicillin and clavulanic acid, after treatment in case of relapse. The bacterial growth will be considered significant if >105 colony-forming unit/ml (CFU/ml) (>104 CFU/ml for urine samples collected by bladder catheterization). Urine cultures containing more than one bacterial species will be considered contaminated.

Participating in This Clinical Trial

Inclusion Criteria

1. Age from 3 months to 5 years;

2. Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) in two consecutive urine samples collected by bladder catheterization or clean catch (19). The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge> 105 CFU /ml as per the Recommendations of the Italian Society of Pediatric Nephrology (SINePe) (19).

Exclusion Criteria

1. "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate dehydration with the need for intravenous antibiotic therapy)

2. Presence of an inserted urinary catheter

3. Immunodeficiency

4. Hypersensitivity to the active substance or other beta-lactam antibiotics

5. Any antibiotic treatment received in the previous 15 days.

6. Presence of another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.)

7. Presence of neurological bladder

8. Presence of phenylketonuria or glucose-galactose malabsorption

9. Intestinal malabsorption

10. Poor compliance

11. History of jaundice or liver failure positive

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS Burlo Garofolo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Egidio Barbi, MD Prof, Study Chair, Institute for maternal and child health Burlo Garofolo
    • Marco Pennesi, MD, Principal Investigator, Institute for maternal and child health Burlo Garofolo
  • Overall Contact(s)
    • Marco Pennesi, MD, 040-3785263, marco.pennesi@burlo.trieste.it

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