Clinical trial • Phase III|Phase IV • Infectious Disease|Other

Amoxicillin; clavulanic acid for Febrile urinary tract infection|Urinary tract infection

Phase III|Phase IV trial of Amoxicillin; clavulanic acid for Febrile urinary tract infection|Urinary tract infection.

Overview

Trial Therapeutic Area
Infectious Disease|Other
Trial Disease
Febrile urinary tract infection|Urinary tract infection
Trial Stage
Phase III|Phase IV
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
13-10-2025
First CTIS Authorization Date
12-02-2026

Trial design

Randomised, open-label, standard arm: amoxicillin/clavulanic acid (augmentin fruit, 400 mg/57 mg/5 ml oral suspension) given as the standard 10-day regimen. intervention arm: personalized therapy with amoxicillin/clavulanic acid continued for 24 hours after fever resolution. specific per-patient dosing and detailed schedule not specified in the provided data.-controlled Phase III|Phase IV trial in Italy.

Randomised
Yes
Open Label
Yes
Comparator
Standard arm: amoxicillin/clavulanic acid (Augmentin Fruit, 400 mg/57 mg/5 ml oral suspension) given as the standard 10-day regimen. Intervention arm: personalized therapy with amoxicillin/clavulanic acid continued for 24 hours after fever resolution. Specific per-patient dosing and detailed schedule not specified in the provided data.
Target Sample Size
520
Trial Duration For Participant
40

Stratification factors

  • sex
  • age

Eligibility

Recruits 520 paediatric patients.

Vulnerable Population
Participants are children aged 3 months to 3 years (vulnerable population). Informed consent must be signed by parents. Subject information and informed consent forms for parents are included in the application (parent ICF documents listed). Assent is not applicable given the participant age range.

Inclusion criteria

  • {"criterion_text":"- Age from 3 months to 3 years"}
  • {"criterion_text":"- Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) on urine samples collected according to Italian Society of Pediatric Nephrology (SINePe) guidelines. The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge >105 CFU/ml (>104 CFU/ml for urine samples collected by bladder catheterization) as per the Recommendations of the SINePe;"}
  • {"criterion_text":"- Informed consent signed by parents"}

Exclusion criteria

  • {"criterion_text":"- 1. \"Complicated\" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate dehydration with the need for intravenous antibiotic therapy);"}
  • {"criterion_text":"- 10. Poor compliance;"}
  • {"criterion_text":"- 11. History of jaundice or liver failure."}
  • {"criterion_text":"- 2. Presence of an inserted urinary catheter;"}
  • {"criterion_text":"- 3. Immunodeficiency;"}
  • {"criterion_text":"- 4. Hypersensitivity to the active substance or other beta-lactam antibiotics;"}
  • {"criterion_text":"- 5. Any antibiotic treatment received in the previous 15 days;"}
  • {"criterion_text":"- 6. Presence of another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.);"}
  • {"criterion_text":"- 7. Presence of neurological bladder;"}
  • {"criterion_text":"- 8. Presence of phenylketonuria or glucose-galactose malabsorption;"}
  • {"criterion_text":"- 9. Intestinal malabsorption;"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Rate of infection recurrence, defined as the reappearance of signs and symptoms of febrile UTI and positive urine culture within 30 days after the end of antibiotic therapy.","definition_or_measurement_approach":"Infection recurrence defined as reappearance of signs and symptoms of febrile UTI plus positive urine culture within 30 days after end of antibiotic therapy."}

Secondary endpoints

  • {"endpoint_text":"- 1. Short-term clinical efficacy between the two groups will be evaluated by clinical assessment and urinalysis during the follow-up.","definition_or_measurement_approach":"Measured by clinical assessment and urinalysis during follow-up to assess complete resolution of signs and symptoms at end of treatment without need for additional/alternative antibiotic therapy."}
  • {"endpoint_text":"- 2. The rate of emergence of antibiotic-resistance or opportunistic strains, 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. It will only be evaluated in suspected relapses by carrying out a urine test and urine culture. The bacterial growth will be considered significant if >105 CF/ml (>104 CFU/ml for urine samples collected by bladder catheterization)","definition_or_measurement_approach":"Evaluated in suspected relapses by urine test and urine culture; bacterial growth considered significant if >10^5 CFU/ml (>10^4 CFU/ml for catheter-collected samples). Resistance defined as culture growth of a single bacterium resistant to amoxicillin/clavulanic acid."}

Recruitment

Planned Sample Size
520
Recruitment Window Months
26
Consent Approach
Informed consent must be signed by parents (parental consent). Subject information and informed consent documents for parents are included in the application (documents L1-L5 listed). No assent process described (participants are 3 months to 3 years). Languages of consent documents not specified in provided data.

Geography

Total Number Of Sites
20
Total Number Of Participants
520

Italy

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
7
Number Of Sites
20
Number Of Participants
520

Sites

Site Name
Santa Maria Degli Angeli Hospital
Department Name
SC Pediatria e Neonatologia
Contact Person Name
Martina Tubaro
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Pediatria
Contact Person Name
Antonio Vergori
Site Name
Ospedale San Bortolo di Vicenza
Department Name
UO Pediatria
Contact Person Name
Chiara Udina
Contact Person Email
chiaraudina@gmail.com
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Pediatria e Nefrologia Pediatrica
Contact Person Name
Milena Brugnara
Contact Person Email
milena.brugnara@aovr.veneto.it
Site Name
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli"
Department Name
UOC Pediatria Generale e Specialistica
Contact Person Name
Pierluigi Marzuillo
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
SOC Nefrologia e Dialisi
Contact Person Name
Luigi Cirillo
Contact Person Email
luigi.cirillo@meyer.it
Site Name
ASST Spedali Civili di Brescia
Department Name
PS Pediatrico - Pediatria d'Urgenza
Contact Person Name
Donatella De Martiis
Contact Person Email
d.demartiis@gmail.com
Site Name
Ospedale Infermi di Rimini
Department Name
Salute Donna, infanzia e adolescenza
Contact Person Name
Claudio La Scola
Contact Person Email
claudio.lascola@auslromagna.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Pediatria
Contact Person Name
Roberto Chimenz
Contact Person Email
rchimenz@unime.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Nefrologia e Dialisi pediatrica - trapianti di rene
Contact Person Name
Francesca Taroni
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
SC Clinica Pediatrica
Contact Person Name
Egidio Barbi
Contact Person Email
egidio.barbi@burlo.trieste.it
Site Name
Ospedale Santa Maria delle Croci
Department Name
Materno infantile
Contact Person Name
Alessandra Iacono
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Neonatologia e Pediatria
Contact Person Name
Angelina Vaccaro
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze della salute della donna, del bambino e di sanità pubblica
Contact Person Name
Antonio Gatto
Site Name
Azienda USL Toscana Centro
Department Name
Pediatria
Contact Person Name
Rino Agostiniani
Site Name
Azienda Ospedale - Università Padova
Department Name
Pediatria
Contact Person Name
Silvia Bressan
Contact Person Email
silvia.bressan.1@unipd.it
Site Name
Ospedale Santa Maria della Misericordia
Department Name
Clinica Pediatrica
Contact Person Name
Francesco Rispoli
Site Name
Azienda USL Toscana Nord Ovest - Ospedale di Cecina
Department Name
Pediatria
Contact Person Name
Antonella Amendolea
Site Name
Ospedale "Morgagni - Pierantoni" di Forlì
Department Name
UO Pediatria
Contact Person Name
Lura Anile
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Materno Infantile
Contact Person Name
Alessia Di Benedetto

Sponsor

Primary sponsor

Full Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Augmentin Fruit, 400 mg/57 mg/5 ml suukaudse suspensiooni pulber
Active Substance
Amoxicillin; clavulanic acid
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number 947217, authorisationCountryCode EE)
Maximum Dose
3 g per day

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