Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
Status:
Not yet recruiting
Trial end date:
2028-05-01
Target enrollment:
Participant gender:
Summary
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 a single dose of IV
antibiotics and switching early to oral antibiotics is as good as 3 days of IV antibiotics.
In other words, this study will compare if a single dose of IV antibiotics plus two days oral
antibiotics (Early Switch) is as clinically effective as 3 days IV antibiotics in resolving
UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in
children presenting to the Emergency Department (ED). All participants will receive a total
of 7 days of antibiotics for the complicated urinary tract infection. If 1 dose and early
switch to 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.
Phase:
Phase 4
Details
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborator:
Royal Children's Hospital
Treatments:
Anti-Bacterial Agents Cephalexin Gentamicins Penicillin G Penicillin G Benzathine Penicillin G Procaine