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Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

Study acronym: CHOICE UTI
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 12% 452 → 396 participants
See other at-risk trials from Murdoch Childrens Research Institute

Record History

  1. Enrollment reduced: 452 → 396 participants Primary completion moved earlier from May 16, 2028 to Jan 2028 · Completion moved earlier from May 16, 2028 to Mar 2028 · Eligibility criteria expanded, about 56 words · 4 more Show 7 more changesShow less
    • Primary completion moved earlier from May 16, 2028 to Jan 2028
    • Completion moved earlier from May 16, 2028 to Mar 2028
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: details revised at 11 of 19 entries
    • Study description expanded, about 18 words
    • Site details revised at 4 of 7 sites
    • Collaborators: details revised at 1 of 1 entry
  2. Study sites: 6 to 7v11
  3. Study sites: 5 to 6 Eligibility criteria shortened, about 18 wordsv10 Show 1 more changeShow less
    • Eligibility criteria shortened, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 185 words Site details revised at 5 of 5 sitesv9 Show 1 more changeShow less
    • Site details revised at 5 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 46 words Study description shortened, about 5 wordsv7 Show 1 more changeShow less
    • Study description shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date changed from estimate of May 16, 2022 to May 30, 2022v6
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 2022 to May 16, 2022 · Study sites: 1 to 5 · Primary and study completion dates: May 2028 to May 16, 2028v5 Show 3 more changesShow less
    • Start date: Mar 2022 to May 16, 2022
    • Study sites: 1 to 5
    • Primary and study completion dates: May 2028 to May 16, 2028
  4. Start date: Jun 2021 to Mar 2022 Primary endpoint revised · Secondary endpoints: 18 to 19 · Study description expanded, about 22 words · 2 morev4 Show 5 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints: 18 to 19
    • Study description expanded, about 22 words
    • Site contact updated
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: May 2021 to Jun 2021v3
  6. Interventions: Benzylpenicillin - single dose (Drug), Benzylpenicillin - three days (Drug), Cefalexin - post single dose of IV antibiotics for the… to Benzylpenicillin - single dose (Drug), Benzylpenicillin - three days (Drug), Cefalexin - post single dose of IV antibiotics for the… Eligibility criteria expanded, about 6 words · Secondary endpoints revised (18) · Study description expanded, about 2 wordsv2 Show 3 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (18)
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04876131
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: Royal Children's Hospital
Conditions Complicated Urinary Tract Infection, Infection, Pediatric Infectious Disease
Enrollment 396 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov