Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Suspected or Confirmed Uncomplicated Urinary Tract Infection. A Single-arm Multicenter Prospective Observational Study.
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).
‣ All children who do not receive any empirical antibiotic therapy but have a positive urine culture can be included if the clinical suspicion of urinary tract infection persists.
‣ A positive urine culture is defined as:
• Suprapubic bladder aspiration: any growth of bacteria.
• Sterile intermittent catheterization: monoculture with ≥10\^3 colony forming units per milliliter (cfu/ml).
• Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^4 cfu/ml.
• Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^5 cfu/ml in one test and 10\^3 cfu/ml in another test.