NCT02475733

Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Months – 17 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a multicentre, multinational, single blind, randomised and active controlled trial of intravenous ceftazidime avibactam in combination with metronidazole versus meropenem. Patients will receive intravenous (IV) treatment for a minimum of 72 hours (3 full days, ie, 9 doses) 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 (PK) 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 (defined as the time point at which first dose of study treatment is administered) at which time there will be a late follow up (LFU) assessment visit. The LFU is to be performed 20 to 35 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 (IV or oral). The maximum duration of IV study drug or oral switch therapy is up to Day 15.

Conditions

• Complicated Intra-abdominal Infections

Interventions

Type	Name	Description
DRUG	Ceftazidime -avibactam	Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment
DRUG	Meropenem	Randomisation (3:1) to CAZ AVI plus metronidazole or meropenem treatment
DRUG	Metronidazole	Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-06-19
• Last updated: 2018-08-09
• Results posted: 2018-08-09

Locations

35 sites across 10 countries: United States, Czechia, Greece, Hungary, Poland, Romania, Russia, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study