Febrile Urinary Tract InfectionPhase 4NCT05301023
Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection
A Phase 4 study testing Individualized antibiotic therapy and Standard antibiotic therapy in people with Febrile Urinary Tract Infection, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.
Trial summary
An investigator-initiated, open-label, multi-center, randomized, non-inferiority trial of children aged 3 months to 13 years with acute uncomplicated febrile urinary tract infection. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Febrile Urinary Tract Infection
- What is being tested?
- Individualized antibiotic therapy and Standard antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 8 sitesDenmark
- Study dates
- 1 Apr 2022to 8 Jun 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical suspicion of febrile (≥38 °C) urinary tract infection.
- Positive urine culture of uropathogenic bacteria obtained by either suprapubic bladder aspiration, sterile intermittent catheterization, or midstream urine.
- Suprapubic bladder aspiration: any growth of bacteria.
- Sterile intermittent catheterization: monoculture with ≥10^3 cfu/ml.
- Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10^4 cfu/ml.
- Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10^5 cfu/ml in one test and 10^3 cfu/ml in another test.
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- Midstream urine x 1 (≥10 years of age): Monoculture with ≥10^5 cfu/ml.
- 3 months to 13 years of age (corrected age in case of premature birth).
- Parents fluent in Danish or English.
- Informed consent both parents.
- All children who do not receive any empirical antibiotic therapy but have a positive urine culture (approximately 48 hours after urine sample collection) can be included if fever (≥ 38.0 °C) is present and the child is initiated with relevant antibiotic therapy. ¨
- Children can be included regardless of whether intravenous or oral antibiotics were given as empirical therapy.
Who cannot join
- Non-Danish civil registration number.
- Not resident in the Capital Region or Region Zealand in Denmark at primary visit.
- Previous inclusion in the trial.
- History of febrile (≥38 °C) urinary tract infection in the last 28 days before the primary visit.
- Antibiotic treatment in the last two weeks before the primary visit.
- Three or more episodes with febrile (≥38 °C) urinary tract infection within one year of the primary visit (including the current episode).
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- Previous complicated episode of febrile (≥38 °C) urinary tract infection (e.g., renal abscess or urosepticemia)
- Non-compliance ≥3 doses of antibiotics during empirical therapy.
- Elevated creatinine.
- Prophylactic antibiotic treatment.
- Known urogenital abnormalities (i.e., obstructing uropathies; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; polycystic kidney disease; neurogenic bladder dysfunction; hypospadias).
- Septic.
- Positive blood culture (if contamination is not suspected).
- Immune deficiency.
- Systemic immunosuppressive therapy.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Copenhagen University Hospital Herlev
Herlev, 2730
Copenhagen University Hospital Hillerød
Hillerød, 3400
Copenhagen University Hospital Holbæk
Holbæk, 4300
Copenhagen University Hospital Hvidovre
Hvidovre, 2650
Copenhagen University Hospital Nykøbing Falster
Nykøbing Falster, 4800
Copenhagen University Hospital Roskilde
Roskilde, 4000
Copenhagen University Hospital Slagelse
Slagelse, 4200
About this study
Official title: Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection
An investigator-initiated, open-label, multi-center, randomized, non-inferiority trial of children aged 3 months to 13 years with acute uncomplicated febrile urinary tract infection. The primary objective is to determine whether individualized antibiotic therapy based on an algorithm (experimental arm) versus standard antibiotic therapy of 10 days (control arm) can reduce the number of days with antibiotic therapy within 28 days after treatment initiation without increasing the risk of recurrent urinary tract infection regardless of the pathogen or death of any cause within 28 days after end of treatment. Children will be randomized 1:1. The medical treatments received are identical in both groups.
- Conditions
- Febrile Urinary Tract Infection
- Being tested
- Individualized antibiotic therapy, Standard antibiotic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized antibiotic therapyOther
Individualized antibiotic therapy is based on the duration of illness after treatment initiation, as the antibiotic therapy can be stopped three days after the participant has become healthy. The participant is classified as healthy if he/she is afebrile (<38.0 °C), has experienced significant clinical improvement, and have no flank pains or dysuria.
Standard antibiotic therapyOther
Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation.
| Study group | Role | What they receive |
|---|---|---|
| Individual group | Experimental | In the individual group, the participants receive individualized antibiotic therapy. Receives: Other: Individualized antibiotic therapy |
| Standard group | Active comparator | In the standard group, the participants receive standard antibiotic therapy as defined by the national guideline. Receives: Other: Standard antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Measured: within 28 days after end of treatment
Number of days with antibiotic therapy
Measured: within 28 days after treatment initiation
Secondary outcomes (2)
Number of days with absence from school or daycare due to illness
Measured: within 28 days after randomization
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Measured: within 100 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Apr 2022
- Primary completion29 Feb 2024
- Study completion8 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Febrile Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Ulrikka Nygaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Naqash Sethi, MD, Principal investigator, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, DenmarkUlrikka Nygaard, Ass. prof, Ph.D., Study chair, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301023
- Sponsor's protocol ID
- H-21057310 (UVI RCT)
- Status last verified
- Jul 2024
- First submitted
- 11 Mar 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan will be shared. Individual participant data (IPD) will be shared to facilitate the conduction of systematic reviews with meta-analysis of individual participant data.
Publications
Sethi NJ, Carlsen ELM, Tabassum A, Cortes D, Mark Ow S, Schmidt IM, Christensen MM, Kirkedal AK, Kai CM, Bjerre CK, Jensen LH, Antonova M, Sonderkaer S, Rytter MJH, Tordrup G, Zaharov T, Sehested LT, Nygaard U. Efficacy and safety of individualised versus standard 10-day antibiotic treatment in children with febrile urinary tract infection (INDI-UTI): a pragmatic, open-label, multicentre, randomised, controlled, non-inferiority trial in Denmark. Lancet Infect Dis. 2025 Aug;25(8):925-935. doi: 10.1016/S1473-3099(25)00075-1. Epub 2025 Apr 2.
PubMed 40187361Sethi N, Carlsen ELM, Schmidt IM, Cortes D, Nygaard U, Sehested LT. Individualised versus standard duration of antibiotic therapy in children with acute uncomplicated febrile urinary tract infection: a study protocol and statistical analysis plan for a multicentre randomised clinical trial. BMJ Open. 2023 Jun 9;13(6):e070888. doi: 10.1136/bmjopen-2022-070888.
PubMed 37295836
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05301023
- Acronym / sponsor ID
- H-21057310 (UVI RCT)
- Conditions
- Febrile Urinary Tract Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 29 Mar 2022 (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.
An investigator-initiated, open-label, multi-center, randomized, non-inferiority trial of children aged 3 months to 13 years with acute uncomplicated febrile urinary tract infection. The primary objective is to determine whether individualized antibiotic therapy based on an algorithm (experimental arm) versus standard antibiotic therapy of 10 days (control arm) can reduce the number of days with antibiotic therapy within 28 days after treatment initiation without increasing the risk of recurrent urinary tract infection regardless of the pathogen or death of any cause within 28 days after end of treatment. Children will be randomized 1:1. The medical treatments received are identical in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual group | Experimental | Other: Individualized antibiotic therapyIn the individual group, the participants receive individualized antibiotic therapy. |
| Standard group | Active comparator | Other: Standard antibiotic therapyIn the standard group, the participants receive standard antibiotic therapy as defined by the national guideline. |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Clinical suspicion of febrile (≥38 °C) urinary tract infection.
- Positive urine culture of uropathogenic bacteria obtained by either suprapubic bladder aspiration, sterile intermittent catheterization, or midstream urine.
- 3 months to 13 years of age (corrected age in case of premature birth).
- Parents fluent in Danish or English.
- Informed consent both parents.
Key exclusion criteria (15 listed)
- Non-Danish civil registration number.
- Not resident in the Capital Region or Region Zealand in Denmark at primary visit.
- Previous inclusion in the trial.
- History of febrile (≥38 °C) urinary tract infection in the last 28 days before the primary visit.
- Antibiotic treatment in the last two weeks before the primary visit.
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 |
|---|---|---|
| Individualized antibiotic therapyIndividualized antibiotic therapy is based on the duration of illness after treatment initiation, as the antibiotic therapy can be stopped three days after the participant has become healthy. The participant is classified as healthy if he/she is afebrile (<38.0 °C), has experienced significant clinical improvement, and have no flank pains or dysuria. | Other | Individual group |
| Standard antibiotic therapyStandard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation. | Other | Standard group |
Primary outcome
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Time frame: within 28 days after end of treatment
Number of days with antibiotic therapy
Time frame: within 28 days after treatment initiation
2 secondary outcomes
Number of days with absence from school or daycare due to illness
Time frame: within 28 days after randomization
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Time frame: within 100 days after end of treatment
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 8 Jul 2024.
- Derived from this study: PubMed 40187361Sethi NJ, Carlsen ELM, Tabassum A, Cortes D, Mark Ow S, Schmidt IM, Christensen MM, Kirkedal AK, Kai CM, Bjerre CK, Jensen LH, Antonova M, Sonderkaer S, Rytter MJH, Tordrup G, Zaharov T, Sehested LT, Nygaard U. Efficacy and safety of individualised versus standard 10-day antibiotic treatment in children with febrile urinary tract infection (INDI-UTI): a pragmatic, open-label, multicentre, randomised, controlled, non-inferiority trial in Denmark. Lancet Infect Dis. 2025 Aug;25(8):925-935. doi: 10.1016/S1473-3099(25)00075-1. Epub 2025 Apr 2.
- Derived from this study: PubMed 37295836Sethi N, Carlsen ELM, Schmidt IM, Cortes D, Nygaard U, Sehested LT. Individualised versus standard duration of antibiotic therapy in children with acute uncomplicated febrile urinary tract infection: a study protocol and statistical analysis plan for a multicentre randomised clinical trial. BMJ Open. 2023 Jun 9;13(6):e070888. doi: 10.1136/bmjopen-2022-070888.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan will be shared. Individual participant data (IPD) will be shared to facilitate the conduction of systematic reviews with meta-analysis of individual participant data.
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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.
Naqash Sethi, MD principal investigator
Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
Ulrikka Nygaard, Ass. prof, Ph.D. study chair
Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
8 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 Individualized antibiotic therapy and Standard antibiotic therapy in people with Febrile Urinary Tract Infection, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.
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 12 inclusion and 15 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. 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?
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause (time frame: within 28 days after end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301023, which also lists 2 linked publications.
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 8 Jul 2024.