Actively Recruiting
CHOICE UTI - Comparing Single Dose IV Antibiotics Plus 2 Days Oral Antibiotics Versus 3 Doses IV Antibiotics for Children With Complicated Urinary Tract Infections in a Multicentre Randomised Trial
Led by Murdoch Childrens Research Institute · Updated on 2025-12-03
452
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Murdoch Childrens Research Institute
Lead Sponsor
R
Royal Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying complicated urinary tract infections (UTIs) in children, which often require hospital stays and intravenous (IV) antibiotics. This trial investigates whether a single dose of IV antibiotics followed by two days of oral antibiotics works as well as three doses of IV antibiotics for treating complicated UTIs in children aged 3 months to 18 years. The goal is to find better treatment methods to reduce hospital stays, avoid unnecessary IV antibiotics, and improve health outcomes for children with complicated UTIs. The trial is a multi-centre, open-label randomized study comparing two treatment approaches. One group receives a single IV dose of antibiotics covering Gram negative bacteria and possibly Enterococcus, followed by two days of oral antibiotics. The other group receives three days of IV antibiotics covering the same bacteria. All participants receive a total of seven days of antibiotics. Treatment starts in the Emergency Department, and oral antibiotics begin within 12 hours after the last IV dose. During the study, children and their parents record symptoms like fever and vomiting in a diary. Follow-ups occur at 72 hours, 14 days, and one month after the first IV dose to monitor symptom resolution, readmissions, antibiotic duration, and quality of life. Researchers also collect urine cultures and imaging results when available. The main outcome is whether symptoms improve by 72 hours after starting treatment. Safety, recurrences, adverse events, and cost-effectiveness are also assessed throughout the trial.
CONDITIONS
Brief Title
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 months (corrected age) and 18 years
- Fever of 38 degrees Celsius or higher related to the illness causing Emergency Department visit
- Presence of at least one complicating feature such as vomiting, chills (rigors), history of recurrent UTI, urological abnormalities, or rapid heartbeat (tachycardia)
- Urine sample collected prior to or within one hour of antibiotic treatment
- Positive urine test showing infection markers (leucocyte esterase >1+, nitrite positive, or specific white blood cell counts) and bacteria present
- Emergency Department clinician determines intravenous antibiotics are required
You will not qualify if you...
- Sepsis requiring inotropic support or large fluid boluses in Emergency Department
- Known allergy to all once daily study drugs (gentamicin, ceftriaxone, or amikacin)
- Co-existing condition needing more than one dose of IV antibiotics (e.g., meningitis)
- Known chronic kidney failure or kidney transplant
- Unrepaired posterior urethral valves
- Indwelling urinary stent with fever
- Previous participation in this trial
- No suitable oral antibiotic option available due to resistance or intolerance
- Previous IV antibiotics given for the same UTI episode
- Suspected kidney abscess
- Clinician does not plan to give more than one IV antibiotic dose initially
- UTI recurrence within 2 weeks
- Unable to obtain consent
- Patient is pregnant
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.
1 visit (in-person) during Emergency Department assessment
Duration - 7 days
Participants receive either a single dose of IV antibiotics followed by 2 days of oral antibiotics, or 3 doses of IV antibiotics over 3 days to treat complicated urinary tract infections.
Initial treatment on Day 1 in the Emergency Department with oral antibiotics starting within 12 hours after last IV dose
Duration - 1 month
Participants are monitored for symptom resolution, readmissions, and any complications through phone or telehealth assessments after treatment.
3 assessments (telehealth or phone) at 72 hours, 14 days, and 1 month after treatment start
Trial Site Locations
Total: 6 locations
1
Women and Children's Hospital
Adelaide, South Australia, Australia
Actively Recruiting
2
University Hospital Geelong
Geelong, Victoria, Australia, 3220
Actively Recruiting
3
Monash Health
Melbourne, Victoria, Australia, 3168
Actively Recruiting
4
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
5
Perth Children's Hospital
Perth, Washington, Australia, 6009
Actively Recruiting
6
Starship Children's Hospital
Auckland, Auckland Province, New Zealand, 1023
Actively Recruiting
Research Team
L
Laila Ibrahim
L
Lucy Hill
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here