Urinary Tract InfectionsPhase 4NCT04400110
Short Therapy for Febrile UTI in Childhood
A Phase 4 study testing Amoxicillin and Clavulanic Acid in Oral Dose Form in people with Urinary Tract Infections, run by IRCCS Burlo Garofolo at 13 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Amoxicillin and Clavulanic Acid in Oral Dose Form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 13 sitesItaly
- Study dates
- 8 Jun 2020to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 3 months to 5 years;
- 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).
Who cannot join
- "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate 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 another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.)
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- Presence of neurological bladder
- Presence of phenylketonuria or glucose-galactose malabsorption
- Intestinal malabsorption
- Poor compliance
- History of jaundice or liver failure positive
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Ospedali Riuniti di Ancona - Ospedale Salesi
Ancona, The Marches, 60123
San Martino Hospital
Belluno, Veneto, 32100
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
A.O.U.G. Martino
Messina, Sicily, 98124
Fondazione IRCSS Ca Granda, Policlinico di Milano
Milan, Lombardy, 20122
Ospedale San Polo
Monfalcone, Friuli Venezia Giulia, 34074
Department of Woman and Child Health, University of Padua City
Padua, Veneto, 35128
Pediatric Department, Santa Maria degli Angeli Hospital
Pordenone, Friuli Venezia Giulia, 33170
Santa Maria delle Croci Hospital
Ravenna, Emilia-Romagna, 48121
Fondazione Policlinico Agostino Gemelli - IRCCS City Rome
Rome, Lazio, 00168
UOC Pediatria Ospedale Ca' Foncello
Treviso, Veneto, 31100
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
ASUIUD Azienda sanitaria universitaria integrata di Udine
Udine, Friuli Venezia Giulia, 33100
About this study
Official title: Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial
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.
- Conditions
- Urinary Tract Infections
- Being tested
- Amoxicillin and Clavulanic Acid in Oral Dose Form
- Keywords
- short antibiotic therapy, urinary tract infection, children
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin and Clavulanic Acid in Oral Dose FormDrug
50 mg/kg three times daily administered orally
| Study group | Role | What they receive |
|---|---|---|
| Short treatment group | Experimental | Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days Receives: Drug: Amoxicillin and Clavulanic Acid in Oral Dose Form |
| Standard treatment group | Active comparator | amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days Receives: Drug: Amoxicillin and Clavulanic Acid in Oral Dose Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 30 days after the end of the intervention
Secondary outcomes (2)
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)
Measured: 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.
Measured: within 30 days after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start8 Jun 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egidio Barbi, MD Prof, Study chair, Institute for maternal and child health Burlo GarofoloMarco Pennesi, MD, Principal investigator, Institute for maternal and child health Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400110
- Sponsor's protocol ID
- RC 10/18
- Status last verified
- Mar 2023
- First submitted
- 19 May 2020
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04400110
- Acronym / sponsor ID
- RC 10/18
- Conditions
- Urinary Tract Infections
- Keywords
- short antibiotic therapy, urinary tract infection, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short treatment group | Experimental | Drug: Amoxicillin and Clavulanic Acid in Oral Dose FormAmoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days |
| Standard treatment group | Active comparator | Drug: Amoxicillin and Clavulanic Acid in Oral Dose Formamoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age from 3 months to 5 years;
- 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).
Key exclusion criteria (11 listed)
- "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin and Clavulanic Acid in Oral Dose Form50 mg/kg three times daily administered orally | Drug | Short treatment group, Standard treatment group |
Primary outcome
Rate of infection recurrence
Time frame: 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
2 secondary outcomes
Rate of complete resolution of signs and symptoms
Time frame: within 30 days after the end of the intervention
Rate of antibiotic-resistant or of opportunistic strains in relapses
Time frame: within 30 days after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egidio Barbi, MD Prof study chair
Institute for maternal and child health Burlo Garofolo
Marco Pennesi, MD principal investigator
Institute for maternal and child health Burlo Garofolo
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin and Clavulanic Acid in Oral Dose Form in people with Urinary Tract Infections, run by IRCCS Burlo Garofolo at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of infection recurrence (time frame: within 30 days after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.