Clinical Trial: Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Childern Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Metronida
Brief 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 Summary: 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.
Sponsor: AstraZeneca
Current Primary Outcome:
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: from the start of IV study treatment up to 35 days after the end of study treatment (IV or oral) ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with serious adverse events as a measure of safety and tolerability [ Time Frame: from the start of IV study treatment up to 35 days after the end of study treatment (IV or oral) ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with laboratory tests as a measure of safety and tolerability [ Time Frame: within 24 hours before first dose of IV study drug ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with laboratory tests as a measure of safety and tolerability [ Time Frame: from 4 days up to 15 days after the first dose of IV study drug ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with laboratory tests as a measure
Original Primary Outcome:
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: from the start of IV study treatment up to 35 days after the end of study treatment (IV or oral) ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with serious adverse events as a measure of safety and tolerability [ Time Frame: from the start of IV study treatment up to 35 days after the end of study treatment (IV or oral) ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with laboratory tests as a measure of safety and tolerability [ Time Frame: within 24 hours before first dose of IV study drug ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with laboratory tests as a measure of safety and tolerability [ Time Frame: from 4 days up to 15 days after the first dose of IV study drug ]Evaluate the safety and tolerability of CAZ AVI plus metronidazole given at the selected dose regimen versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with laboratory tests as a measure
Current Secondary Outcome:
- Number of patients with each clinical outcome [ Time Frame: End of 72 hours treatment ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with each microbiological response [ Time Frame: within 24 hours after completion of the last infusion of study drug or at the time of premature discontinuation of study drug ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with clinical relapse [ Time Frame: Up to 35 days after last dose of any study drug (IV or oral ) ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Plasma concentration of CAZ-AVI from blood sampling [ Time Frame: ±15 minutes following CAZ-AVI infusion ]Evaluate the PK of CAZ AVI in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with each clinical outcome [ Time Frame: within 24 hours after completion of the last infusion of study drug or at the time of premature discontinuation of study drug ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with each clinical outcome [ Time Frame: within 48 hours after the last dose of oral switch therapy ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with each clinical outcome [ Time Frame: Up to Day 15 after last dose of any study drug (IV or oral) ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with each microbiological response [ Time Frame: Within 48 hours after the last dose of oral switch therapy ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with each microbiological response [ Time Frame: Up to Day 15 after last dose of any study drug (IV or oral) ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with each microbiological response [ Time Frame: Up to 35 days after last dose of any study drug (IV or oral ) ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Plasma concentration of CAZ-AVI from blood sampling [ Time Frame: 30 to 90 minutes following CAZ-AVI infusion ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Plasma concentration of CAZ-AVI from blood sampling [ Time Frame: 300 to 360 minutes following CAZ-AVI infusion ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
- Number of patients with emergent infections [ Time Frame: Any occurance from the first study dose until 35 days after last dose of any study drug(IV or oral) ]Evaluate the descriptive efficacy of CAZ AVI plus metronidazole versus meropenem in paediatric patients aged ≥3 months to <18 years with cIAI
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: May 25, 2015
Date Started: July 31, 2015
Date Completion: October 31, 2017
Last Updated: April 28, 2017
Last Verified: April 2017
- Number of patients with each clinical outcome [ Time Frame: End of 72 hours treatment ]
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: from the start of IV study treatment up to 35 days after the end of study treatment (IV or oral) ]
