Actively Recruiting
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.
Led by Rigshospitalet, Denmark · Updated on 2024-07-08
125
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
H
Hvidovre University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study whether oral antibiotic treatment alone is possible and safe for clinically stable children aged between 4 weeks and 2 months who have a suspected or confirmed urinary tract infection and no past high-risk medical history. The study is observational and focuses on uncomplicated urinary tract infections in this young population to evaluate treatment feasibility and safety. Clinically stable children without high-risk medical history will start oral antibiotic therapy using amoxicillin-clavulanic acid given in three doses totaling 50 mg/kg/day. If urine culture sensitivity results are available, a narrower spectrum antibiotic may be used instead. If a child becomes unstable or has a confirmed positive blood culture, treatment will change to parenteral antibiotics such as gentamicin and ampicillin. Children admitted to hospital will be sent home after clinical improvement, typically after at least one day. Participants will undergo a follow-up visit or virtual check approximately 72 hours after starting treatment to monitor improvement and adherence. Antibiotic therapy will last 10 days, during which children will have a renal ultrasound. Researchers will track outcomes including recurrence of urinary tract infection or death within 28 and 100 days after treatment, days admitted for urinary symptoms, and antibiotic-related side effects. The total study period includes treatment and follow-up assessments to monitor safety and treatment success.
CONDITIONS
Brief Title
Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical suspicion of urinary tract infection regardless of fever
- Clinically stable child (no respiratory or circulatory problems, no sepsis or meningeal signs)
- Age between 4 weeks and 2 months (corrected for prematurity)
- Positive urine culture if no empirical antibiotics given but infection still suspected
- Positive urine culture defined by specific bacterial growth criteria based on sample type
You will not qualify if you...
- Non-Danish civil registration number
- High-risk medical history including previous urinary tract infection, prophylactic antibiotic use, known urogenital abnormalities, or prior hospitalization needing antibiotics
- Markedly elevated C-reactive protein indicating bacteremia
- Elevated creatinine levels
- Inability to take oral antibiotics due to frequent vomiting or regurgitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 days
Clinically stable children aged 4 weeks to 2 months with a suspected or confirmed urinary tract infection will initiate oral antibiotic therapy lasting 10 days. Participants will be admitted if empirical antibiotics are needed, and may be sent home when clinically improved. A physical or virtual follow-up occurs on day 3 to ensure clinical improvement and treatment adherence. Renal ultrasound will be performed within the treatment period.
1 admission visit and 1 follow-up visit approximately 3 days after treatment initiation
Duration - Up to 100 days after treatment ends
Participants are monitored for recurrence of infection or adverse events up to 28 days after the end of treatment, with additional monitoring up to 100 days for infection recurrence and antibiotic resistance.
Trial Site Locations
Total: 4 locations
1
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
2
Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Actively Recruiting
3
Copenhagen University Hospital Hillerød
Hillerød, Denmark, 3400
Actively Recruiting
4
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
N
Naqash Sethi, MD
U
Ulrikka Nygaard, Ass. prof, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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