Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections

Systemic Infections Clinical Trial

Official title: A Phase I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam (CAZ-AVI) in Children From 3 Months of Age to <18 Years Who Are Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Infection

Status Completed

Clinical Trial Summary

To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.

Clinical Trial Description

This is a phase I, open-label, single-dose study. The study aims to characterize the pharmacokinetics of CAZ-AVI and assess its safety and tolerability following a single IV dose given to hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection. This study will include 4 cohorts, each consisting of at least 8 evaluable pediatric patients, aged ≥3 months to <18 years, who are hospitalized with infections. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Sepsis
• Systemic Infections

• NCT number: NCT01893346
• Study type: Interventional
• Source: Pfizer
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: October 2014