Complicated Urinary Tract Infections Clinical Trial
Official title:
A Single Blind, Randomised, Multi-centre, Active Controlled, Trial To Evaluate Safety, Tolerability, Pharmacokinetics And Efficacy Of Ceftazidime And Avibactam Compared With Cefepime In Children From 3 Months To Less Than 18 Years Of Age With Complicated Urinary Tract Infections (Cutis)
This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with complicated urinary tract infections.
This study will be a single-blind, randomised, multi-centre, active controlled trial.
Patients aged from 3 months to less than 18 years with complicated urinary tract infections
(cUTIs) will be randomised to 1 of 2 treatment groups (3:1 ratio): Ceftazidime and avibactam
(CAZ AVI )or cefepime. Randomisation will be stratified by age cohort.
Patients will receive intravenous (IV) treatment for a minimum of 72 hours (3 full days, ie,
9 doses if given 3 times daily, or 6 doses if given twice daily) before having the option to
switch to an oral therapy . The decision to switch to oral therapy is entirely at the
Investigator's discretion, if the patient has good or sufficient clinical response, and the
patient is tolerating oral fluids or food.
Patients will be assessed for safety and efficacy throughout the study, and blood samples
will be taken for pharmacokinetic assessment. The duration of each patient's participation in
the study will be a minimum of 27 days to a maximum of 50 days after start of study treatment
including (intravenous treatment or oral switch therapy) 7 to 14 days of active treatment.
The late follow-up visit (LFU) is to be performed 20 to 36 days after the last dose of any
treatment.
The assessments at the test of cure (TOC) visit should be performed in person 8 to 15 days
after last dose of any study drug Maximum duration of study drug or oral switch therapy is up
to Day 14.
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