Short Therapy for Febrile UTI in Childhood

NCT04400110 | Completed Phase 4 DMC

• 1 other identifier: RC 10/18
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 13

Brief 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

Urinary Tract Infections

Keywords

short antibiotic therapy; urinary tract infection; children

Outcome Measures

Primary Outcomes (1)

• Rate of infection recurrence

  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

  within 30 days after the end of the intervention

Secondary Outcomes (2)

• Rate of complete resolution of signs and symptoms

  within 30 days after the end of the intervention

• Rate of antibiotic-resistant or of opportunistic strains in relapses

  within 30 days after the end of the intervention

Study Arms (2)

Short treatment group

EXPERIMENTAL

Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days

Drug: Amoxicillin and Clavulanic Acid in Oral Dose Form

Standard treatment group

ACTIVE COMPARATOR

amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days

Drug: Amoxicillin and Clavulanic Acid in Oral Dose Form

Interventions

Amoxicillin and Clavulanic Acid in Oral Dose Form DRUG

50 mg/kg three times daily administered orally

Short treatment group; Standard treatment group

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 3 months to 5 years;
• 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).

You may not qualify if:

• "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate 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 another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.)
• Presence of neurological bladder
• Presence of phenylketonuria or glucose-galactose malabsorption
• Intestinal malabsorption
• Poor compliance
• History of jaundice or liver failure positive

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (13)

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Santa Maria delle Croci Hospital

Ravenna, Emilia-Romagna, 48121, Italy

Location

Ospedale San Polo

Monfalcone, Friuli Venezia Giulia, 34074, Italy

Location

Pediatric Department, Santa Maria degli Angeli Hospital

Pordenone, Friuli Venezia Giulia, 33170, Italy

Location

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

ASUIUD Azienda sanitaria universitaria integrata di Udine

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Fondazione Policlinico Agostino Gemelli - IRCCS City Rome

Rome, Lazio, 00168, Italy

Location

Fondazione IRCSS Ca Granda, Policlinico di Milano

Milan, Lombardy, 20122, Italy

Location

A.O.U.G. Martino

Messina, Sicily, 98124, Italy

Location

Ospedali Riuniti di Ancona - Ospedale Salesi

Ancona, The Marches, 60123, Italy

Location

San Martino Hospital

Belluno, Veneto, 32100, Italy

Location

Department of Woman and Child Health, University of Padua City

Padua, Veneto, 35128, Italy

Location

UOC Pediatria Ospedale Ca' Foncello

Treviso, Veneto, 31100, Italy

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Amoxicillin; Clavulanic Acid; Dosage Forms

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Egidio Barbi, MD Prof

  Institute for maternal and child health Burlo Garofolo

  STUDY CHAIR

• Marco Pennesi, MD

  Institute for maternal and child health Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: June 8, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)