Shortened antibiotic therapy in urinary tract infections in childhood

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001941-41-IT

Enrollment

520

Registered

2021-05-24

Start date

2020-04-21

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FEBRILE URINARY TRACT INFECTION MedDRA version: 20.1 Level: LLT Classification code 10000822 Term: Acute kidney infection System Organ Class: 100000004862

Interventions

Trade Name: amoxicillina acido clavulanico Product Name: AMOXICILLINA TRIIDRATO POTASSIO CLAVULANATO Product Code: [037954043] Pharmaceutical Form: Oral suspension INN or Proposed INN: AMOXICILLINA TR

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - "Complicated" febrile urinary tract infection (septic appearance, repeated vomiting with the impossibility to take the antibiotic by mouth, moderate severe-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 other chronic, uncontrolled medical condition - Neurological bladder - Phenylketonuria or glucose-galactose malabsorption - Intestinal malabsorption - Need for hospitalization - poor compliance.

Design outcomes

Primary

Measure	Time frame
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;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;Primary end point(s): Rate of infection recurrence after the discontinuance of antibiotic therapy;Timepoint(s) of evaluation of this end point: 30 days after the end of the treatment	—

Measure

Time frame

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;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;Primary end point(s): Rate of infection recurrence after the discontinuance of antibiotic therapy;Timepoint(s) of evaluation of this end point: 30 days after the end of the treatment

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Contacts

Public ContactUfficio Ricerca Clinica

IRCCS materno infantile Burlo Garofolo

sperimentazioni.cliniche@burlo.trieste.it+390403785411

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026