CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Ceftazidime -avibactam +2 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.

Search/NCT02475733
NCT02475733Phase 2Completed
CompareCT.gov

A Single Blind, Randomised, Multi-centre, Active Controlled, Trial To Evaluate Safety, Tolerability, Pharmacokinetics And Efficacy Of Ceftazidime And Avibactam When Given In Combination With Metronidazole, Compared With Meropenem, In Children From 3 Months To Less Than 18 Years Of Age With Complicated Intra-abdominal Infections (cIAIs)

Pfizer·interventional·Posted Jun 19, 2015·Updated Aug 9, 2018

In Brief

A Phase 2 clinical trial evaluating Ceftazidime -avibactam, Meropenem, and 1 other intervention for Complicated Intra-abdominal Infections. Completed, enrolled 83 participants across 35 sites in 10 countries.

Detailed Summary

This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam and metronidazole versus meropenem in paediatric population (from 3 months to less than 18 years of age )with complicated intra-abdominal infections (cIAIs)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Intra-abdominal Infections
CountriesCzechia, Greece, Hungary, Poland, Romania, Russia, Spain, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 19, 2015
Enrollment StartAug 1, 2015
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.0 years ago

Interventions

Ceftazidime -avibactamdrug

Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment

Meropenemdrug

Randomisation (3:1) to CAZ AVI plus metronidazole or meropenem treatment

Metronidazoledrug

Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment