Short Therapy for Febrile UTI in Childhood

NCT ID: NCT04400110

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short treatment group

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

Group Type: EXPERIMENTAL

Amoxicillin and Clavulanic Acid in Oral Dose Form

Intervention Type: DRUG

50 mg/kg three times daily administered orally

Standard treatment group

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

Group Type: ACTIVE_COMPARATOR

Amoxicillin and Clavulanic Acid in Oral Dose Form

Intervention Type: DRUG

50 mg/kg three times daily administered orally

Interventions

Amoxicillin and Clavulanic Acid in Oral Dose Form

50 mg/kg three times daily administered orally

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Egidio Barbi, MD Prof

Role: STUDY_CHAIR

Institute for maternal and child health Burlo Garofolo

Marco Pennesi, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for maternal and child health Burlo Garofolo

Locations

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

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, Italy

ASUIUD Azienda sanitaria universitaria integrata di Udine

Udine, Friuli Venezia Giulia, Italy

Fondazione Policlinico Agostino Gemelli - IRCCS City Rome

Rome, Lazio, Italy

Fondazione IRCSS Ca Granda, Policlinico di Milano

Milan, Lombardy, Italy

A.O.U.G. Martino

Messina, Sicily, Italy

Ospedali Riuniti di Ancona - Ospedale Salesi

Ancona, The Marches, Italy

San Martino Hospital

Belluno, Veneto, Italy

Department of Woman and Child Health, University of Padua City

Padua, Veneto, Italy

UOC Pediatria Ospedale Ca' Foncello

Treviso, Veneto, Italy

Countries

Italy

Other Identifiers

RC 10/18

Identifier Type: -

Identifier Source: org_study_id