At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 97 enrolled
Drug / intervention
Ceftazidime -avibactam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Ceftazidime -avibactam and Cefepime for Complicated Urinary Tract Infections. Completed, enrolled 97 participants across 28 sites in 9 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Urinary Tract Infections
CountriesCzechia, Greece, Hungary, Poland, Romania, Russia, Taiwan, Turkey (Türkiye), United States
CollaboratorsPRA Health Sciences
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartSep 2015
Primary CompletionSep 2017
TodayJul 2026
First PostedJul 15, 2015
Enrollment StartSep 24, 2015
Primary CompletionSep 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.0 years ago
Interventions
Ceftazidime -avibactamdrug
Patients randomised (3:1) to the CAZ-AVI or cefepime treatment
Cefepimedrug
Patients randomised (3:1) to the CAZ-AVI or cefepime treatment