Could a single IV antibiotic dose send kids home sooner?
NCT ID NCT04876131
First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This study compares a single dose of IV antibiotics followed by two days of oral antibiotics against the standard three days of IV antibiotics for children with complicated urinary tract infections (UTIs). The goal is to see if the shorter IV course is just as effective at resolving symptoms within 72 hours. If it works, it could reduce hospital stays and the risks of unnecessary IV treatment. The trial involves 452 children aged 3 months to 18 years with complicating factors like vomiting or urological issues.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- antibiotics (benzylpenicillin and gentamicin)
- What this could lead to
- If successful, this could shorten hospital stays for children with complicated UTIs by allowing them to go home sooner on oral antibiotics.
- What could go wrong
- This is a phase 4 trial, but it's still possible that a single IV dose may not control the infection as well as three doses, leading to prolonged symptoms or treatment failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 452 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2022
- Expected to finish
-
May 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
3 months to 18 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 3 months (corrected age) to 18 years * Fever (reported fever at home or measured fever of ≥38 degrees Celsius associated with the illness that triggered current ED presentation (eg fever may have been 18 hours prior to presentation but none since then because patient has been on maximal antipyretics - paracetamol or ibuprofen) * Any of the following complicating features: Vomiting, Rigors, History of recurrent UTI, Urological abnormalities, Tachycardia * Urine sample available (Urine culture must have been collected prior to or within an hour of antibiotic treatment, either at the GP or ED - in order to assess urine culture as per below). * Abnormal urinary dipstick leucocyte esterase \>1+ or nitrite positive OR ≥5 White Blood Cells (WBCs) per high-power field in centrifuged urine OR≥ 10 White Blood Cells (WBCs) per mm3 in uncentrifuged urine and bacteriuria with any bacteria per high-power field * ED clinician determines the child requires treatment with IV antibiotics \* In ED, only urine dipstick or urinalysis will be available. Once urine culture is available, to be included in the efficacy analysis, culture results must meet the following criteria: Positive urine culture result with no more than 2 species of microorganisms AND Spontaneously voided urine with ≥105 microorganisms per mL of urine or Suprapubic aspirate or urinary catheter with ≥104 microorganisms per mL of urine. In the absence of a positive urine culture, ultrasonographic findings supporting pyelonephritis (per reporting radiologist) will be accepted as evidence of a urinary tract infection. Exclusion Criteria: * Sepsis (requiring inotropic support or more than 20ml/kg of fluid bolus in Emergency Department) * Known allergy to all once daily study drug options (gentamicin or ceftriaxone or amikacin) * If the patient has another co-existing condition which requires (based on established evidence-based guidelines) more than 1 dose of IV antibiotics eg meningitis * Known chronic renal failure or renal transplant patients * Unrepaired posterior urethral valves * Indwelling stent and fever * Previously enrolled participants in the CHOICE UTI trial. * No available oral antibiotic option for this UTI: urine culture result already available and multi-resistant organism with susceptibility only to IV antibiotics or known intolerance to oral antibiotics (previous UTI with multi-resistant organism not an exclusion) * Previous IV antibiotics for same UTI episode eg interhospital transfer whereby significant time has passed since first dose IV * Patients with clinically suspected renal abscess e.g., extreme renal tenderness, out of keeping with pyelonephritis (clinically determined). * Clinician does not intend on prescribing a course of IV antibiotics but plans on only giving a single dose from the outset * Recurrence of urinary tract infection within 2 weeks * Unable to obtain consent * Patient is pregnant
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Complicated urinary tract infection are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
7 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Flinders Medical Centre
RECRUITINGAdelaide, South Australia, 5042, Australia
-
Monash Health
RECRUITINGMelbourne, Victoria, 3168, Australia
-
Perth Children's Hospital
RECRUITINGPerth, Washington, 6009, Australia
-
Royal Children's Hospital
RECRUITINGParkville, Victoria, 3052, Australia
-
Starship Children's Hospital
RECRUITINGAuckland, Auckland Province, 1023, New Zealand
-
University Hospital Geelong
RECRUITINGGeelong, Victoria, 3220, Australia
-
Women and Children's Hospital
RECRUITINGAdelaide, South Australia, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple blood test predict sepsis two days early?
- Switching stomach drugs after transplant may tame a deadly immune attack
- Can telemedicine bring IV antibiotics home?
- Can a new antibiotic combo tame tough UTIs in kids?
- Blood test may forecast recovery in elderly infection patients
- Aging in place: could mobile teams keep nursing home residents out of the hospital?