Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection

Launched by RIGSHOSPITALET, DENMARK · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether giving oral antibiotics alone is safe and effective for young children, aged 4 weeks to 2 months, who have a urinary tract infection (UTI). The researchers want to find out if this method works well for children who are stable and don’t have a history of serious health issues. To be eligible for the study, children must show signs of a UTI, like having bacteria in their urine, but they should not be experiencing severe health problems or have a past of frequent UTIs or other related medical conditions.

If a child is chosen to participate, they will receive oral antibiotics without any other treatments. The study is currently looking for participants, and it aims to help doctors understand better ways to treat UTIs in young children. Parents can expect their child to be closely monitored during the study to ensure their safety and well-being. Overall, this trial could provide important insights into treating UTIs in infants safely and effectively.

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • 1. Clinical suspicion of urinary tract infection irrespective of the presence of fever.
• • 2. Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
• • 3. 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 CRITERIA:
• • 1. Non-Danish civil registration number.
• • 2. High-risk medical history.
• • 1. Previous urinary tract infection.
• • 2. Prophylactic antibiotic treatment.
• • 3. 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).
• • 4. Previous hospitalization needing antibiotic therapy.
• • 3. Markedly elevated c-reactive protein indicating bacteremia.
• • 4. Elevated creatinine.
• • 5. Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).