Safety and Tolerability of Ceftazidime-Avibactam for pediatric patients with suspected or confirmed infections

Study identifier:D4280C00014

ClinicalTrials.gov identifier:NCT01893346

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Systemic Infections

Phase

Phase 1

Healthy volunteers

No

Study drug

CAZ-AVI

Sex

All

Actual Enrollment

35

Study type

Interventional

Age

3 Months - 17 Years

Date

Study Start Date: 01 Jul 2013
Primary Completion Date: 01 Oct 2014
Study Completion Date: 01 Oct 2014

Study design

Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Sept 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Cerexa, Inc.

Inclusion and exclusion criteria