Study identifier:D4280C00014
ClinicalTrials.gov identifier:NCT01893346
EudraCT identifier:N/A
CTIS identifier:N/A
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
Systemic Infections
Phase 1
No
CAZ-AVI
All
35
Interventional
3 Months - 17 Years
Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
Cerexa, Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: CAZ-AVI This arm will include 4 cohorts. Patients will be stratified by age. | Drug: CAZ-AVI Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort. |