Status:
COMPLETED
Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Hvidovre University Hospital
Conditions:
Febrile Urinary Tract Infection
Eligibility:
All Genders
3-12 years
Phase:
PHASE4
Brief 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. The primary objec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2024
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT05301023
Start Date
April 1 2022
End Date
June 8 2024
Last Update
July 8 2024
Active Locations (8)
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1
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
2
Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
3
Copenhagen University Hospital Hillerød
Hillerød, Denmark, 3400
4
Copenhagen University Hospital Holbæk
Holbæk, Denmark, 4300