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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
50 mg/kg three times daily administered orally
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
...and 3 more locations
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
Time frame: within 30 days after the end of the intervention
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)
Time frame: within 30 days after the end of the intervention
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.
Time frame: within 30 days after the end of the intervention
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