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NCT Number: NCT05301023

Individualized Antibiotic Therapy in Children With Acute Uncomplicated 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.

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Key information

Conditions

Febrile Urinary Tract Infection

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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.

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

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.

Standard antibiotic therapy

Other

Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation.

Primary outcomes

  1. 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

  2. Number of days with antibiotic therapy

    Time frame: within 28 days after treatment initiation

Secondary outcomes

  1. Number of days with absence from school or daycare due to illness

    Time frame: within 28 days after randomization

  2. 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

Other outcomes

  1. Number of hospital days related to urinary tract infection symptoms

    Time frame: within 28 days after end of treatment

  2. Number of days with a physical or virtual (phone or online) consultation

    Time frame: From date of randomization until the date of treatment stop for the baseline infection, assessed up to 14 days

  3. Proportion of participants with recurrent infection with a bacterium resistant to the antibiotic given for the primary infection

    Time frame: within 100 days after end of treatment

  4. Proportion of participants with a serious adverse event

    Time frame: within 100 days after randomization

    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

  5. Proportion of participants with an antibiotic-related non-serious adverse event

    Time frame: within 28 days after randomization

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2022
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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