Urinary Tract Infections
Conditions
Keywords
short antibiotic therapy, urinary tract infection, children
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.
Interventions
DRUGAmoxicillin and Clavulanic Acid in Oral Dose Form
50 mg/kg three times daily administered orally
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed