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

NCT01893346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-09-06

Study results available
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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.

Conditions

  • Systemic Infections

Interventions

DRUG

CAZ-AVI

Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Paul Newell, MBBS, MRCP · AstraZeneca

  • John Bradley, MD · University of California, San Diego

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01893346 on ClinicalTrials.gov