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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual group | Experimental | In the individual group, the participants receive individualized antibiotic therapy. |
|
| Standard group | Active Comparator | In the standard group, the participants receive standard antibiotic therapy as defined by the national guideline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized antibiotic therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause | within 28 days after end of treatment | |
| Number of days with antibiotic therapy | within 28 days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with absence from school or daycare due to illness | within 28 days after randomization | |
| Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause | within 100 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospital days related to urinary tract infection symptoms | within 28 days after end of treatment | |
| Number of days with a physical or virtual (phone or online) consultation | From date of randomization until the date of treatment stop for the baseline infection, assessed up to 14 days |
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naqash Sethi, MD | Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark | Principal Investigator |
| Ulrikka Nygaard, Ass. prof, Ph.D. | Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Copenhagen University Hospital Herlev |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40187361 | Derived | 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. | |
| 37295836 |
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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.
Beginning 3 months and ending 5 years following article publication.
Primarily for the conduction of individual participant data meta-analysis.
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|
| Standard antibiotic therapy | Other | Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation. |
|
| Proportion of participants with recurrent infection with a bacterium resistant to the antibiotic given for the primary infection | within 100 days after end of treatment |
| Proportion of participants with a serious adverse event | Defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, or jeopardizes the patient | within 100 days after randomization |
| Proportion of participants with an antibiotic-related non-serious adverse event | within 28 days after randomization |
| Herlev |
| 2730 |
| Denmark |
| Copenhagen University Hospital Hillerød | Hillerød | 3400 | Denmark |
| Copenhagen University Hospital Holbæk | Holbæk | 4300 | Denmark |
| Copenhagen University Hospital Hvidovre | Hvidovre | 2650 | Denmark |
| Copenhagen University Hospital Nykøbing Falster | Nykøbing Falster | 4800 | Denmark |
| Copenhagen University Hospital Roskilde | Roskilde | 4000 | Denmark |
| Copenhagen University Hospital Slagelse | Slagelse | 4200 | Denmark |
| Derived |
| Sethi 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. |