Short Therapy for Febrile UTI in Childhood

Urinary Tract Infections Clinical Trial

Official title:

Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400110
• Other study ID #: RC 10/18
• Status: Completed
• Phase: Phase 4
• Start date: June 8, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedali Riuniti di Ancona - Ospedale Salesi	Ancona	Marche
Italy	San Martino Hospital	Belluno	Veneto
Italy	Policlinico S.Orsola-Malpighi	Bologna	Emilia Romagna
Italy	A.O.U.G. Martino	Messina	Sicilia
Italy	Fondazione IRCSS Ca Granda, Policlinico di Milano	Milano	Lombardia
Italy	Ospedale San Polo	Monfalcone	Friuli Venezia Giulia
Italy	Department of Woman and Child Health, University of Padua City	Padua	Veneto
Italy	Pediatric Department, Santa Maria degli Angeli Hospital	Pordenone	Friuli Venezia Giulia
Italy	Santa Maria delle Croci Hospital	Ravenna	Emilia Romagna
Italy	Fondazione Policlinico Agostino Gemelli - IRCCS City Rome	Roma	Lazio
Italy	UOC Pediatria Ospedale Ca' Foncello	Treviso	Veneto
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

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of complete resolution of signs and symptoms	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)	within 30 days after the end of the intervention
Secondary	Rate of antibiotic-resistant or of opportunistic strains in relapses	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.	within 30 days after the end of the intervention