RECRUITING Phase 4 ClinicalTrials.gov

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

Sponsor: Murdoch Childrens Research Institute • ClinicalTrials.gov ID: NCT04876131

Registry updated: 2026-10-09

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Description

Urinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7 days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions for IV antibiotics and constitute a major burden for healthcare systems. There is considerable variation in care for children who present with UTI and have complicating features such as vomiting, dehydration, urological abnormalities or have a previous history of UTI. Australian and international guidelines lack clear, evidence-based recommendations to guide treatment in this group. Without gold standard evidence, these children will continue to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes. This multicentre, non-inferiority randomised trial will investigate if One dose - single dose of IV followed by 2 days oral antibiotics is as non-inferior to Three doses for children with UTI and co-existing complicating factors presenting to the Emergency Department (ED). In other words, this study will compare if a single dose of IV antibiotics plus two days oral antibiotics is as clinically effective as 3 doses antibiotics in resolving UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to the ED. All participants will receive a total of 7 days of antibiotics for the complicated urinary tract infection. If 1 dose IV and 2 days oral antibiotics is found to be as good as 3 days, the duration of IV antibiotics for complicated UTI can be reduced along with avoidance of the inherent risks of unnecessary hospital admission by administering a single IV dose in an outpatient/ED setting. On the other hand if a single IV dose results in prolonged symptoms or treatment failure, this will inform practice for the proportion of children who have a single dose of IV antibiotics in the ED and are sent home on oral antibiotics. Regardless of the outcome, this trial will inform clinical practice for complicated UTI to improve health outcomes for this group.

Interventions

Benzylpenicillin - single dose (Drug)
Participants will receive a single dose of IV antibiotic (benzylpenicillin). Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours.
Benzylpenicillin - three days (Drug)
Participants will receive three days of this IV antibiotic (benzylpenicillin). Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours. For severe infections, use up to 60 mg/kg (maximum 2.4 g) every 4-6 hours.
Gentamicin - single dose (Drug)
Participants will receive a single dose of IV antibiotic (gentamicin). Gentamicin dosing: Children ≤10 years old: 7.5 mg/kg (maximum dose 320 mg) Children \>10 years old: 6-7 mg/kg (maximum dose 560 mg)
Gentamicin - three days (Drug)
Participants will receive three days of this IV antibiotic (gentamicin). Gentamicin dosing: Children ≤10 years old: 7.5 mg/kg (maximum dose 320 mg) Children \>10 years old: 6-7 mg/kg (maximum dose 560 mg)
Cefalexin - post single dose of IV antibiotics for the remaining two days (Drug)
Oral antibiotic will be as per local guidelines. i.e. Cefalexin 25mg/kg (maximum dosage 500mg) 4 times a day or 33mg/kg (maximum dosage 500mg) 3 times a day

Eligibility criteria

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. In the absence of a positive urine culture or supportive ultrasonographic findings, a case will also be accepted as presumed UTI where the treating clinician has provided a diagnosis of UTI and treated the patient accordingly. 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

Conditions

Complicated Urinary Tract Infection Infection Pediatric Infectious Disease

Locations

Flinders Medical Centre — Adelaide, South Australia, Australia
Women and Children's Hospital — Adelaide, South Australia, Australia
University Hospital Geelong — Geelong, Victoria, Australia
Monash Health — Melbourne, Victoria, Australia
Royal Children's Hospital — Parkville, Victoria, Australia
Perth Children's Hospital — Perth, Washington, Australia
Starship Children's Hospital — Auckland, Auckland Province, New Zealand

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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