Back to resultsShort Therapy for Febrile UTI in Childhood
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Amoxicillin and Clavulanic Acid in Oral Dose Form
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections focused on measuring short antibiotic therapy, urinary tract infection, children
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- "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
Sites / Locations
- Policlinico S.Orsola-Malpighi
- Santa Maria delle Croci Hospital
- Ospedale San Polo
- Pediatric Department, Santa Maria degli Angeli Hospital
- Institute for Maternal and Child Health IRCCS Burlo Garofolo
- ASUIUD Azienda sanitaria universitaria integrata di Udine
- Fondazione Policlinico Agostino Gemelli - IRCCS City Rome
- Fondazione IRCSS Ca Granda, Policlinico di Milano
- Ospedali Riuniti di Ancona - Ospedale Salesi
- A.O.U.G. Martino
- San Martino Hospital
- Department of Woman and Child Health, University of Padua City
- UOC Pediatria Ospedale Ca' Foncello
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Short treatment group
Standard treatment group
Arm Description
Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days
amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04400110
Brief Title
Short Therapy for Febrile UTI in Childhood
Official Title
Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
short antibiotic therapy, urinary tract infection, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short treatment group
Arm Type
Experimental
Arm Description
Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days
Arm Title
Standard treatment group
Arm Type
Active Comparator
Arm Description
amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin and Clavulanic Acid in Oral Dose Form
Intervention Description
50 mg/kg three times daily administered orally
Primary Outcome Measure Information:
Title
Rate of infection recurrence
Description
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
Time Frame
within 30 days after the end of the intervention
Secondary Outcome Measure Information:
Title
Rate of complete resolution of signs and symptoms
Description
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)
Time Frame
within 30 days after the end of the intervention
Title
Rate of antibiotic-resistant or of opportunistic strains in relapses
Description
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.
Time Frame
within 30 days after the end of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
"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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egidio Barbi, MD Prof
Organizational Affiliation
Institute for maternal and child health Burlo Garofolo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco Pennesi, MD
Organizational Affiliation
Institute for maternal and child health Burlo Garofolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico S.Orsola-Malpighi
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Santa Maria delle Croci Hospital
City
Ravenna
State/Province
Emilia Romagna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Ospedale San Polo
City
Monfalcone
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34074
Country
Italy
Facility Name
Pediatric Department, Santa Maria degli Angeli Hospital
City
Pordenone
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
33170
Country
Italy
Facility Name
Institute for Maternal and Child Health IRCCS Burlo Garofolo
City
Trieste
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34137
Country
Italy
Facility Name
ASUIUD Azienda sanitaria universitaria integrata di Udine
City
Udine
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Fondazione Policlinico Agostino Gemelli - IRCCS City Rome
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCSS Ca Granda, Policlinico di Milano
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedali Riuniti di Ancona - Ospedale Salesi
City
Ancona
State/Province
Marche
ZIP/Postal Code
60123
Country
Italy
Facility Name
A.O.U.G. Martino
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98124
Country
Italy
Facility Name
San Martino Hospital
City
Belluno
State/Province
Veneto
ZIP/Postal Code
32100
Country
Italy
Facility Name
Department of Woman and Child Health, University of Padua City
City
Padua
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
UOC Pediatria Ospedale Ca' Foncello
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Short Therapy for Febrile UTI in Childhood
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