Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
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.
Rigshospitalet, Denmark
125 participants
Feb 27, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria9
- Non-Danish civil registration number.
- High-risk medical history.
- Previous urinary tract infection.
- Prophylactic antibiotic treatment.
- Known urogenital abnormality (i.e., hydronephrosis (pyelectasis ≥10 mm or/and caliectasis ≥5 mm); hydroureter; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; ectopic placed kidneys; polycystic kidney disease; neurogenic bladder dysfunction; and hypospadias).
- Previous hospitalization needing antibiotic therapy.
- Markedly elevated c-reactive protein indicating bacteremia.
- Elevated creatinine.
- Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Empirical 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.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05819229