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Short Therapy for Febrile UTI in Childhood

NCT04400110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-03-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Amoxicillin and Clavulanic Acid in Oral Dose Form

50 mg/kg three times daily administered orally

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Egidio Barbi, MD Prof · Institute for maternal and child health Burlo Garofolo

  • Marco Pennesi, MD · Institute for maternal and child health Burlo Garofolo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04400110 on ClinicalTrials.gov