The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.
Clinical suspicion of urinary tract infection irrespective of the presence of fever.
Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
4 weeks to 2 months of age (corrected age, if premature).
Suprapubic bladder aspiration: any growth of bacteria.
Non-Danish civil registration number.
High-risk medical history.
Previous urinary tract infection.
Prophylactic antibiotic treatment.
All children aged 4 weeks to 2 months who are referred by their primary physician or the medical helpline 1813 (outside the work hours of their primary physician) to one of four pediatric emergency departments in the Capital Region of Denmark with suspected urinary tract infection.
Cohort
Prospective
Oral antibiotic therapy
DrugEmpirical choice: amoxicillin-clavulanic acid 50 mg/kg/day divided into three doses. If the sensitivity pattern is available, another oral antibiotic, preferably smaller-spectrum, can be used instead. Total duration of antibiotic therapy will be 10 days.
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Number of days admitted related to urinary tract symptoms
Number of days with antibiotic-related non-serious adverse events.
Data on diarrhea, loss of appetite, and vomiting will be included.
Proportion of participants with a recurrent urinary tract infection regardless of the pathogen or death of any cause.
Proportion of participants with a recurrent infection with a bacterium resistant to the antibiotic given for the baseline infection or an opportunistic infection
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
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Rigshospitalet, Denmark
Lead sponsor
Hvidovre University Hospital
Collaborator
