Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a single IV antibiotic dose send kids home sooner?

NCT ID NCT04876131

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Vår säkerhetsrekommendation!

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.

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Adelaide, South Australia, 5042, Australia

  • Monash Health

    RECRUITING

    Melbourne, Victoria, 3168, Australia

  • Perth Children's Hospital

    RECRUITING

    Perth, Washington, 6009, Australia

  • Royal Children's Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Starship Children's Hospital

    RECRUITING

    Auckland, Auckland Province, 1023, New Zealand

  • University Hospital Geelong

    RECRUITING

    Geelong, Victoria, 3220, Australia

  • Women and Children's Hospital

    RECRUITING

    Adelaide, South Australia, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.