Shortened antibiotic therapy for febrile urinary tract infections (UTI) in childhood: a multicentre randomized controlled trial

INTERVENTION: Trade Name: amoxicillina acido clavulanico Product Name: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Product Code: [037954043] Pharmaceutical Form: Oral suspension INN or Proposed INN: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Current Sponsor code: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 80‐ Trade Name: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Product Name: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Product Code: [NA] Pharmaceutical Form: Oral suspension INN or Proposed INN: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Current Sponsor code: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 80‐ CONDITION: FEBRILE URINARY TRACT INFECTION ; MedDRA version: 20.1 Level: LLT Classification code 10000822 Term: Acute kidney infection System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: To assess if a five days oral course of amoxicillin and calvulanic acid is non‐inferior to the standard ten‐day regimen in the treatment of febrile urinary tract infections in children Primary end point(s): Rate of infection recurrence after the discontinuance of antibiotic therapy Secondary Objective: ‐ to evaluate short‐term clinical efficacy defined as the complete resolution of the signs and symptoms related to the infection at the end of the treatment whitout the need of additional or alternative antibiotic therapy; ‐ to evaluate the presence of antibiotic‐resistant or opportunistic strains in relapses Timepoint(s) of evaluation of this end point: 30 days after the end of the treatment SECONDARY OUTCOME: Secondary end point(s): ‐ short term clinical efficacy at the end of the treatment cycle, defined as the complete resolution of the signs and symptoms related to pyelonephritis during treatment, without the need for additional or alternative antibiotic therapy, evaluated at the first follow‐up;; ‐ occurrance of adverse events (nausea, diarrhea, headache); ‐ the emergence of antibiotic resistance or opportunistic strains, defined as the presence of positive urine (nitrite and / or leukocyte esterase) and positive urine culture for a single type of bacterium, resistant to amoxicillin‐clavulanic acid. It will be evaluated only in suspected relapses through the execution of urine and urine culture. Timepoint(s) of evaluation of this end point: 5 days after the end of the treatment; 5 days after the end of the treatment; 30 days after the end of the treatment INCLUSION CRITERIA: ‐ age from 3 months to 5 years ‐ clinical diagnosis of febrile urinary tract infection, defined by fever > or = 38 °C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) in two consecutive urine samples collected by bladder catheterization or clan catch Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range