Short Therapy for Febrile UTI in Childhood

Phase 4

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: Amoxicillin and Clavulanic Acid in Oral Dose Form

• Registration Number: NCT04400110
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Study Start: 2020-06-08
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Standard treatment group	Amoxicillin and Clavulanic Acid in Oral Dose Form	amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days
Short treatment group	Amoxicillin and Clavulanic Acid in Oral Dose Form	Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days

Primary Outcome Measures

Name	Time	Method
Rate of infection recurrence	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 Outcome Measures

Name	Time	Method
Rate of complete resolution of signs and symptoms	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	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.

Trial Locations

Locations (13)

San Martino Hospital; 🇮🇹 Belluno, Veneto, Italy

ASUIUD Azienda sanitaria universitaria integrata di Udine; 🇮🇹 Udine, Friuli Venezia Giulia, Italy

Ospedali Riuniti di Ancona - Ospedale Salesi; 🇮🇹 Ancona, Marche, Italy

Institute for Maternal and Child Health IRCCS Burlo Garofolo; 🇮🇹 Trieste, Friuli Venezia Giulia, Italy

Fondazione IRCSS Ca Granda, Policlinico di Milano; 🇮🇹 Milano, Lombardia, Italy

A.O.U.G. Martino; 🇮🇹 Messina, Sicilia, Italy

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Emilia Romagna, Italy

Santa Maria delle Croci Hospital; 🇮🇹 Ravenna, Emilia Romagna, Italy

Ospedale San Polo; 🇮🇹 Monfalcone, Friuli Venezia Giulia, Italy

Pediatric Department, Santa Maria degli Angeli Hospital; 🇮🇹 Pordenone, Friuli Venezia Giulia, Italy

UOC Pediatria Ospedale Ca' Foncello; 🇮🇹 Treviso, Veneto, Italy

Fondazione Policlinico Agostino Gemelli - IRCCS City Rome; 🇮🇹 Roma, Lazio, Italy

Department of Woman and Child Health, University of Padua City; 🇮🇹 Padua, Veneto, Italy